Methods for Providing Beneficial Effects to the Oral Cavity

ABSTRACT

A method for providing a beneficial effect to an oral cavity of a mammal, the method including contacting a plurality of surfaces of the oral cavity with a liquid effective for providing the beneficial effect to the oral cavity and providing reciprocation of the liquid over the plurality of surfaces of the oral cavity under conditions effective to provide the beneficial effect.

FIELD OF THE INVENTION

This application is a divisional application, which claims the benefitof U.S. patent application Ser. No.12/844,885 filed Jul. 28, 2010 andalso claims the benefit of U.S. provisional application 61/229,839 filedJul. 30, 2009, the complete disclosure of which is hereby incorporatedherein by reference for all purposes.

The present invention relates to methods for providing a beneficialeffect to the oral cavity of a mammal.

BACKGROUND OF THE INVENTION

In addition to regular professional dental checkups, daily oral hygieneis generally recognized as an effective preventative measure against theonset, development, and/or exacerbation of periodontal disease,gingivitis and/or tooth decay. Unfortunately, however, even the mostmeticulous individuals dedicated to thorough brushing and flossingpractices often fail to reach, loosen and remove deep-gum and/or deepinter-dental food particulate, plaque or biofilm. Most individuals haveprofessional dental cleanings binaurally to remove tarter deposits.

For many years products have been devised to facilitate the simple homecleaning of teeth, although as yet a single device which is simple touse and cleans all surfaces of a tooth and/or the gingival orsub-gingival areas simultaneously is not available. The conventionaltoothbrush is widely utilized, although it requires a significant inputof energy to be effective and, furthermore, a conventional toothbrushcannot adequately clean the inter-proximal areas of the teeth. Cleaningof the areas between teeth currently requires the use of floss, pick, orsome such other additional device apart from a toothbrush.

Electric toothbrushes have achieved significant popularity and, althoughthese reduce the energy input required to utilize a toothbrush, they arestill inadequate to ensure proper inter-proximal tooth cleaning. Oralirrigators are known to clean the inter-proximal area between teeth.However, such devices have a single jet which must be directed at theprecise inter-proximal area involved in order to remove debris. Thesewater pump type cleaners are therefore typically only of significantvalue in connection with teeth having braces thereupon which often traplarge particles of food. It will be appreciated that if both debris andplaque are to be removed from teeth, at present a combination of anumber of devices must be used, which is extremely time consuming andinconvenient.

In addition, in order for such practices and devices to be effective, ahigh level of consumer compliance with techniques and/or instructions isrequired. The user-to-user variation in time, cleaning/treating formula,technique, etc., will affect the cleaning of the teeth.

The present invention ameliorates one or more of the above mentioneddisadvantages with existing oral hygiene apparatus and methods, or atleast provides the market with an alternative technology that isadvantageous over known technology, and also may be used to ameliorate adetrimental condition or to improve cosmetic appearance of the oralcavity.

SUMMARY OF THE INVENTION

The invention is a method for providing a beneficial effect to an oralcavity of a mammal, the method comprising contacting a plurality ofsurfaces of the oral cavity with a liquid effective for providing thebeneficial effect to the oral cavity and providing reciprocation of theliquid over the plurality of surfaces of the oral cavity underconditions effective to provide the beneficial effect.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic drawing of one embodiment of a system used inmethods according to the present invention;

FIG. 2 is a schematic drawing of an alternative embodiment of a systemused in methods according to the present invention;

FIG. 3 is a schematic drawing of another alternative embodiment of asystem used in methods according to the present invention;

FIG. 4 is a schematic drawing of yet another alternative embodiment of asystem used in methods according to the present invention;

FIG. 5 is a schematic drawing of a multiple cleaning solution embodimentof a system used in methods according to the present invention;

FIG. 6a is a perspective drawing of an embodiment of a reciprocatingflow controller used in methods according to the present invention;

FIG. 6b is an exploded view of the reciprocating flow controller of FIG.6 a;

FIG. 6c is a cross-sectional view of the reciprocating flow controllerof FIG. 6a in its first position;

FIG. 6d is a cross-sectional view of the reciprocating flow controllerof FIG. 6a in its second position;

FIG. 7a is a perspective drawing of a first alternative embodiment of areciprocating flow controller used in methods according to the presentinvention;

FIG. 7b is a top view of the reciprocating flow controller of FIG. 7a inits first position;

FIG. 7c is a top view of the reciprocating flow controller of FIG. 7a inits second position;

FIG. 8a is an exploded view of a second alternative embodiment of areciprocating flow controller used in methods according to the presentinvention;

FIG. 8b is a perspective drawing of the reciprocating flow controller ofFIG. 8 a;

FIG. 8c is a side view of the reciprocating flow controller of FIG. 8ain its first position;

FIG. 9a is a perspective drawing of a third alternative embodiment of areciprocating flow controller used in methods according to the presentinvention;

FIG. 9b is an exploded view of the reciprocating flow controller of FIG.9 a;

FIG. 9c is a top view of the reciprocating flow controller of FIG. 9a inits first position;

FIG. 9d is a top view of the reciprocating flow controller of FIG. 9a inits second position;

FIG. 10a is a perspective drawing of a fourth alternative embodiment ofa reciprocating flow controller used in methods according to the presentinvention;

FIG. 10b is a side view of the reciprocating flow controller of FIG. 10a;

FIG. 10c is a top view of the reciprocating flow controller of FIG. 10ain its first position;

FIG. 10d is a top view of the reciprocating flow controller of FIG. 10ain its second position;

FIG. 11a is a perspective drawing of a fifth alternative embodiment of areciprocating flow controller used in methods according to the presentinvention;

FIG. 11b is a top view of the reciprocating flow controller of FIG. 11ain its first position;

FIG. 11c is a top view of the reciprocating flow controller of FIG. 11ain its second position;

FIG. 12 is a top front perspective view of a first embodiment of anapplication tray used in methods according to the present invention;

FIG. 13 is a bottom rear perspective view of the embodiment of theapplication tray of FIG. 12;

FIG. 14 is a vertical sectional view of the application tray of FIG. 12;

FIG. 15 is a horizontal sectional view of the application tray of FIG.12;

FIG. 16 is a top back perspective view of a second embodiment of anapplication tray used in methods according to the present invention;

FIG. 17 is a top front perspective view of the embodiment of theapplication tray of FIG. 16;

FIG. 18 is a top view of the application tray of FIG. 16;

FIG. 19 is a cut-away view of the application tray of FIG. 16;

FIG. 20 is a top front perspective view of a third embodiment of anapplication tray used in methods according to the present invention;

FIG. 21 is a top back view of the embodiment of the application tray ofFIG. 20;

FIG. 22 is a bottom back view of the embodiment of the application trayof FIG. 20;

FIG. 23 is a cut-away view of the application tray of FIG. 20;

FIG. 24a is an exploded view of an embodiment of a hand piece used inmethods according to the present invention;

FIG. 24b is an exploded view of the pumping section of the hand piece ofFIG. 24 a;

FIG. 24c is an exploded view of the vacuum section of the hand piece ofFIG. 24 a;

FIG. 24d is a side view of the drive system of the pumping and drivingsections of the hand piece of FIG. 24 a;

FIG. 24e is a cut-away view of the hand piece of FIG. 24 a;

FIG. 25a is a back, top perspective view of an embodiment of a systemused in methods according to the present invention;

FIG. 25b is a front, top perspective view of the system of FIG. 25 a;

FIG. 25c is a back, top perspective view of the system of FIG. 25a ,with the base station liquid reservoir attached to the base station; and

FIG. 25d is a front, top perspective view of the system of FIG. 25a ,with the base station liquid reservoir attached to the base station.

DETAILED DESCRIPTION OF THE INVENTION

The terms “reciprocating movement of liquid(s)” and “reciprocation ofliquid(s)” are used interchangeably herein. As used herein, both termsmean alternating the direction of flow of the liquid(s) back and forthover surfaces of the oral cavity of a mammal from a first flow directionto a second flow direction that is opposite the first flow direction.

By “effective fit or seal”, it is meant that the level of sealingbetween the means for directing liquid onto and about the plurality ofsurfaces in the oral cavity, e.g. an application tray, is such that theamount of leakage of liquid from the tray into the oral cavity duringuse is sufficiently low so as to reduce or minimize the amount of liquidused and to maintain comfort of the user, e.g. to avoid choking orgagging. Without intending to be limited, gagging is understood to be areflex (i.e. not an intentional movement) muscular contraction of theback of the throat caused by stimulation of the back of the soft palate,the pharyngeal wall, the tonsillar area or base of tongue, meant to be aprotective movement that prevents foreign objects from entering thepharynx and into the airway. There is variability in the gag reflexamong individuals, e.g. what areas of the mouth stimulate it. Inaddition to the physical causes of gagging, there may be a psychologicalelement to gagging, e.g. people who have a fear of choking may easilygag when something is placed in the mouth.

As used herein, “means for conveying liquid” includes structures throughwhich liquid may travel or be transported throughout the systems anddevices utilized in methods according to the invention and includes,without limitation passages, conduits, tubes, ports, portals, channels,lumens, pipes and manifolds. Such means for conveying liquids may beutilized in devices for providing reciprocation of liquids and means fordirecting liquids onto and about surfaces of the oral cavity. Suchconveying means also provide liquid to the directing means and providesliquid to the reciprocation means from a reservoir for containingliquid, whether the reservoir is contained within a hand-held devicecontaining the reciprocation means or a base unit. The conveying meansalso provides liquid from a base unit to a liquid reservoir containedwithin the hand-held device. Described herein are methods, devices andsystems useful in providing a beneficial effect to an oral cavity of amammal, e.g. a human.

Methods of the invention entail contacting a plurality of surfaces ofthe oral cavity with a liquid that is effective for providing thedesired beneficial effect to the oral cavity. In such methods,reciprocation of the liquid(s) over the plurality of surfaces of theoral cavity is provided under conditions effective to provide thedesired beneficial effect to the oral cavity. Contact of the pluralityof surfaces by the liquid may be conducted substantially simultaneous.By substantially simultaneous, it is meant that, while not all of theplurality of surfaces of the oral cavity are necessarily contacted bythe fluid at the same time, the majority of the surfaces are contactedsimultaneously, or within a short period of time to provide an overalleffect similar to that as if all surfaces are contacted at the sametime.

The conditions for providing the desired beneficial effect in the oralcavity may vary depending on the particular environment, circumstancesand effect being sought. The different variables are interdependent inthat they create a specific velocity of the liquid. The velocityrequirement may be a function of the formulation in some embodiments.For example, with change in the viscosity, additives, e.g. abrasives,shear thinning agents, etc., and general flow properties of theformulation, velocity requirements of the jets may change to produce thesame level of efficacy. Factors which may be considered in order toprovide the appropriate conditions for achieving the particularbeneficial effect sought include, without limitation, the velocityand/or flow rate and/or pressure of the liquid stream, pulsation of theliquid, the spray geometry or spray pattern of the liquid, thetemperature of the liquid and the frequency of the reciprocating cycleof the liquid.

The liquid pressures, i.e. manifold pressure just prior to exit throughthe jets, may be from about 0.5 psi to about 30 psi, or from about 3 toabout 15 psi, or about 5 psi. Flow rate of liquid may be from about 10ml/s to about 60 ml/s, or about 20 ml/s to about 40 ml/s. It should benoted that the larger and higher quantity of the jets, the greater flowrate required at a given pressure/velocity. Pulse frequency (linked topulse length and delivery (ml/pulse), may be from about 0.5 Hz to about50 Hz, or from about 5 Hz to about 25 Hz. Delivery pulse duty cycle maybe from about 10% to 100%, or from about 40% to about 60%. It is notedthat at 100% there is no pulse, but instead a continuous flow of liquid.Delivery pulse volume (total volume through all jets/nozzles) may befrom about 0.2 ml to about 120 ml, or from about 0.5 ml to about 15 ml.Velocity of jetted pulse may be from about 4 cm/s to about 400 cm/s, orfrom about 20 cm/s to about 160 in/s. Vacuum duty cycle may be fromabout 10% to 100%, or from about 50% to 100%. It is noted that vacuum isalways on at 100%. Volumetric delivery to vacuum ratio may be from about2:1 to about 1:20, or from about 1:1 to 1:10.

Once having the benefit of this disclosure, one skilled in the art willrecognize that the various factors may be controlled and selected,depending on the particular circumstances and desired benefit sought.

The liquid(s) will include at least one ingredient, or agent, effectivefor providing the beneficial effect sought, in an amount effective toprovide the beneficial effect when contacted with the surfaces of theoral cavity. For example, the liquid may include, without limitation, aningredient selected from the group consisting of a cleaning agent, anantimicrobial agent, a mineralization agent, a desensitizing agent, asurfactant and a whitening agent. In certain embodiments, more than oneliquid may be used in a single session. For example, a cleaning solutionmay be applied to the oral cavity, followed by a second solutioncontaining, for example, a whitening agent or an antimicrobial agent.Solutions also may include a plurality of agents to accomplish more thanone benefit with a single application. For example, the solution mayinclude both a cleansing agent and an agent for ameliorating adetrimental condition, as further discussed below. In addition, a singlesolution may be effective to provide more than one beneficial effect tothe oral cavity. For example, the solution may include a single agentthat both cleans the oral cavity and acts as an antimicrobial, or thatboth cleans the oral cavity and whitens teeth.

Liquids useful for improving the cosmetic appearance of the oral cavitymay include a whitening agent to whiten teeth in the cavity. Suchwhitening agents may include, without limitation, hydrogen peroxide andcarbamide peroxide, or other agents capable of generating hydrogenperoxide when applied to the teeth. Such agents are well known withinthe art related to oral care whitening products such as rinses,toothpastes and whitening strips. Other whitening agents may includeabrasives such as silica, sodium bicarbonate, alumina, apatites andbioglass.

It is noted that, while abrasives may serve to clean and/or whiten theteeth, certain of the abrasives also may serve to amelioratehypersensitivity of the teeth caused by loss of enamel and exposure ofthe tubules in the teeth. For example, the particle size, e.g. diameter,of certain of the materials, e.g. bioglass, may be effective to blockexposed tubules, thus reducing sensitivity of the teeth.

In some embodiments, the liquid may comprise an antimicrobialcomposition containing an alcohol having 3 to 6 carbon atoms. The liquidmay be an antimicrobial mouthwash composition, particularly one havingreduced ethanol content or being substantially free of ethanol,providing a high level of efficacy in the prevention of plaque, gumdisease and bad breath. Noted alcohols having 3 to 6 carbon atoms arealiphatic alcohols. A particularly aliphatic alcohol having 3 carbons is1-propanol.

In one embodiment the liquid may comprise an antimicrobial compositioncomprising (a) an antimicrobial effective amount of thymol and one ormore other essential oils, (b) from about 0.01% to about 70. 0% v/v, orabout 0.1% to about 30% v/v, or about 0.1% to about 10% v/v, or about0.2% to about 8% v/v, of an alcohol having 3 to 6 carbon atoms and (c) avehicle. The alcohol may be 1-propanol. The liquid vehicle can beaqueous or non-aqueous, and may include thickening agents or gellingagents to provide the compositions with a particular consistency. Waterand water/ethanol mixtures are the preferred vehicle.

Another embodiment of the liquid is an antimicrobial compositioncomprising (a) an antimicrobial effective amount of an antimicrobialagent, (b) from about 0.01% to about 70% v/v, or about 0.1% to about 30%v/v, or about 0.2% to about 8% v/v, of propanol and (c) a vehicle. Theantimicrobial composition of this embodiment exhibits unexpectedlysuperior delivery system kinetics compared to prior art ethanolicsystems. Exemplary antimicrobial agents which may be employed include,without limitation, essential oils, cetyl pyidium chloride (CPC),chlorhexidine, hexetidine, chitosan, triclosan, domiphen bromide,stannous fluoride, soluble pyrophosphates, metal oxides including butnot limited to zinc oxide, peppermint oil, sage oil, sanguinaria,dicalcium dihydrate, aloe vera, polyols, protease, lipase, amylase, andmetal salts including but not limited to zinc citrate, and the like. Aparticularly preferred aspect of this embodiment is directed to anantimicrobial oral composition, e.g. a mouthwash having about 30% v/v orless, or about 10% v/v or less, or about 3% v/v or less, of 1-propanol.

Yet another embodiment of the liquid is a reduced ethanol, antimicrobialmouthwash composition which comprises (a) an antimicrobial effectiveamount of thymol and one or more other essential oils; (b) from about0.01 to about 30.0% v/v, or about 0.1% to about 10% v/v, or about 0.2%to about 8% v/v, of an alcohol having 3 to 6 carbon atoms; (c) ethanolin an amount of about 25% v/v or less; (d) at least one surfactant; and(e) water. Preferably the total concentration of ethanol and alcoholhaving 3 to 6 carbon atoms is no greater than 30% v/v, or no greaterthan 25% v/v, or no greater than 22% v/v.

In still another embodiment, the liquid is an ethanol-free antimicrobialmouthwash composition which comprises (a) an antimicrobial effectiveamount of thymol and one or more other essential oils; (b) from about0.01% to about 30.0% v/v, or about 0.1% to about 10% v/v, or about 0.2%to about 8%, of an alcohol having 3 to 6 carbon atoms; (c) at least onesurfactant; and (d) water.

The alcohol having 3 to 6 carbon atoms is preferably selected from thegroup consisting of 1-propanol, 2-propanol, 1-butanol, 2-butanol,tert-butanol and corresponding diols. 1-Propanol and 2-propanol arepreferred, with 1-propanol being most preferred.

In addition to generally improving the oral hygiene of the oral cavityby cleaning, for example, removal or disruption of plaque build-up, foodparticles, biofilm, etc., the inventions are useful to amelioratedetrimental conditions within the oral cavity and to improve thecosmetic appearance of the oral cavity, for example whitening of theteeth. Detrimental conditions may include, without limitation, caries,gingivitis, inflammation, symptoms associated with periodontal disease,halitosis, sensitivity of the teeth and fungal infection. The liquidsthemselves may be in various forms, provided that they have the flowcharacteristics suitable for use in devices and methods of the presentinvention. For example, the liquids may be selected from the groupconsisting of solutions, emulsions and dispersions. In certainembodiments, the liquid may comprise a particulate, e.g. an abrasive,dispersed in a liquid phase, e.g. an aqueous phase. In such cases, theabrasive would be substantially homogeneously dispersed in the aqueousphase in order to be applied to the surfaces of the oral cavity. Inother embodiments, an oil-in-water or water-in-oil emulsion may be used.In such cases, the liquid will comprise a discontinuous oil phasesubstantially homogeneously dispersed within a continuous aqueous phase,or a discontinuous aqueous phase substantially homogenously dispersed ina continuous oil phase, as the case may be. In still other embodiments,the liquid may be a solution whereby the agent is dissolved in acarrier, or where the carrier itself may be considered as the agent forproviding the desired beneficial effect, e.g., an alcohol oralcohol/water mixture, usually having other agents dissolved therein.

Disclosed herein are devices, e.g. oral care devices, for example adental cleaning apparatus, suitable for in-home use and adapted todirect liquid onto a plurality of surfaces of a tooth and/or thegingival area, as well as methods and systems utilizing such devices. Incertain embodiments the surfaces of the oral cavity are contacted by theliquid substantially simultaneously. As used herein, reference to thegingival area includes, without limitation, reference to thesub-gingival pocket. The appropriate liquid is directed onto a pluralityof surfaces of teeth and/or gingival area substantially simultaneouslyin a reciprocating action under conditions effective to providecleaning, and/or general improvement of the cosmetic appearance of theoral cavity and/or amelioration of a detrimental condition of the teethand/or gingival area, thereby providing generally improved oral hygieneof teeth and/or gingival area. For example, one such device cleans teethand/or the gingival area and removes plaque using an appropriatecleaning liquid by reciprocating the liquid back and forth over thefront and back surfaces and inter-proximal areas of the teeth, therebycreating a cleaning cycle while minimizing the amount of cleaning liquidused.

Devices on that provide reciprocation of the liquid comprise a means forcontrolling reciprocation of the liquid. The controlling means includemeans for conveying the liquid to and from a means for directing theliquid onto the plurality of surfaces of the oral cavity. In certainembodiments, the means for providing reciprocation of the liquidcomprises a plurality of portals for receiving and discharging theliquid, a plurality of passages, or conduits, through which the liquidis conveyed, and means for changing the direction of flow of the liquidto provide reciprocation of the liquid, as described in more detailherein below. The controlling means may be controlled by a logic circuitand/or a mechanically controlled circuit.

In certain embodiments, devices for providing reciprocation may includea means for attaching or connecting the device to a reservoir forcontaining the liquid. The reservoir may be removably attached to thedevice. In this case, the reservoir and the device may comprise meansfor attaching one to the other. After completion of the process, thereservoir may be discarded and replaced with a different reservoir, ormay be refilled and used again. In other embodiments, the reciprocatingdevice will include a reservoir integral with the device. In embodimentswhere the device may be attached to a base unit, as described herein,the reservoir, whether integral with the device or removably attached tothe device, may be refilled from a supply reservoir which forms a partof the base unit. Where a base unit is utilized, the device and the baseunit will comprise means for attaching one to the other.

The device will comprise a power source for driving the means forreciprocating liquids. The power source may be contained within thedevice, e.g. in the handle of the device, for example, batteries,whether rechargeable or disposable. Where a base unit is employed, thebase may include means for providing power to the device. In otherembodiments, the base unit may include means for recharging therechargeable batteries contained within the device.

Devices for providing reciprocation of liquids will include means forattaching the device to means for directing the liquid onto theplurality of surfaces of the oral cavity, e.g. an application tray ormouthpiece. In certain embodiments, the directing means providessubstantially simultaneous contact of the plurality of surfaces of theoral cavity by the liquid. The attachment means may provide removableattachment of the mouthpiece to the device. In such embodiments,multiple users may use their own mouthpiece with the single devicecomprising the reciprocating means. In other embodiments, the attachmentmeans may provide a non-removable attachment to the mouthpiece, wherebythe mouthpiece is an integral part of the device. Devices for providingreciprocation as described above may be contained within a housing alsocontaining other device components so as to provide a hand-held devicesuitable for providing liquid to the directing means, as describedherein below.

The means for directing the liquid onto the surfaces of the oral cavity,e.g. an application tray or mouthpiece, is comprised of multiplecomponents. The directing means comprises a chamber for maintaining theliquid proximate the plurality of surfaces, i.e.liquid-contacting-chamber (LCC). By “proximate”, it is meant that theliquid is maintained in contact with the surfaces. The LCC is defined bythe space bounded by the front inner wall and rear inner wall of themouthpiece, and a wall, or membrane, extending between and integral withthe front and rear inner walls of the mouthpiece, and in certainembodiments, a rear gum-sealing membrane. Together, the front and rearinner walls, the wall extending there between and rear gum-sealingmembrane form the LCC membrane (LCCM). The general shape of the LCCM isthat of a “U” or an “n”, depending on the orientation of the mouthpiece,which follows the teeth to provide uniform and optimized contact by theliquid. The LCCM may be flexible or rigid depending on the particulardirecting means. The membrane may be located as a base membrane of theLCCM. The front and rear inner walls of the LCCM each include aplurality of openings, or slots, through which the liquid is directed tocontact the plurality of surfaces of the oral cavity.

The LCCM design may be optimized for maximum effectiveness as it relatesto the size, shape, thickness, materials, volume created around theteeth/gingiva, nozzle design and placement as it relates to the oralcavity and the teeth in conjunction with the manifold and gingivalmargin seal to provide comfort and minimize the gagging reflex of theuser. The combination of the above provides effective contact of theteeth and gingival area by the liquid.

The LCCM provides a controlled and isolated environment with knownvolume, i.e. the LCC, to contact teeth and/or gingival area withliquids, and then to remove spent liquids, as well as debris, plaque,etc., from the LCC without exposing the whole oral cavity to liquid,debris, etc. This decreases the potential for ingestion of the liquids.The LCCM also allows increased flow rates and pressure of liquidswithout drowning the individual nozzles when significant flow rates arerequired to provide adequate cleaning, for example. The LCCM also allowsreduced liquid quantities and flow rates when required, as only the areawithin the LCC is being contacted with liquid, not the entire oralcavity. The LCCM also allows controlled delivery and duration of contactof liquid on, through and around teeth and the gingival area, allowingincreased concentrations of liquids on the area being contacted by theliquid, thereby providing more effective control and delivery of liquid.

The thickness of the walls of the LCCM may be within a range of 0.2 mmto 1.5 mm, to provide necessary physical performance properties, whileminimizing material content, and optimizing performance. The distancebetween the inner walls of the LCCM to the teeth may be from about 0.1mm to about 5 mm, and more typically an average distance of about 2.5 mmto provide maximum comfort, while minimizing customization and LCCvolume requirements.

The size and shape of the mouthpiece preferably utilizes three basicuniversal sizes (small, medium and large) for both the top and bottomteeth, but the design provides mechanisms to allow different levels ofcustomization as required to ensure comfort and functionality to theindividual user. The device may incorporate a switching mechanism, whichwould allow it to be operable only when in the correct position in themouth. The mouthpiece may include both upper and lower sections toprovide substantially simultaneous contact of the plurality of surfacesof the oral cavity by liquid. In an alternate embodiment the upper andlower sections may be cleaned utilizing a single bridge that could beused on the upper or lower teeth and gums of the user (first placed oneportion for cleaning, then subsequently placed over the other portionfor cleaning).

The number and location of openings, also referred to herein as slots,jets or nozzles, contained within the inner walls of the mouthpiecethrough which the liquid is directed will vary and be determined basedupon the circumstances and environment of use, the particular user andthe beneficial effect being sought. The cross-sectional geometry of theopenings may be circular, elliptical, trapezoidal, or any other geometrythat provides effective contact of the surfaces of the oral cavity bythe liquid. The location and number of openings may be designed todirect jets of liquid in a variety of spray patterns effective forproviding the desired beneficial effect. Opening diameters may be fromabout 0.1 to about 3 mm, or from about 0.2 mm to about 0.8 mm, or about0.5 mm, to provide effective cleaning and average jet velocities andcoverage.

Optimal opening placement and direction/angles allows coverage ofsubstantially all teeth surfaces in the area if the oral cavity to becontacted by liquid, including but not limited to interdental, top,side, back, and gingival pocket surfaces. In alternate embodiments, theopenings could be of different sizes and different shapes to providedifferent cleaning, coverage and spray patterns, to adjust velocities,density and fan patterns (full cone, fan, partial, cone, jet), or due toformulation consideration. Nozzles could also be designed to be tubularand or extend from the LCC membrane to provide directed spray, or act assprinkler like mechanism to provide extended coverage across the teeth,similar to a hose sprinkler system. The nozzles are preferably integralto the inner walls of the LCC membrane and can be incorporated into theinner walls through any number of assembly or forming techniques knownin the art (insert molded, formed in membrane through machining,injection molding, etc.).

The LCCM may be an elastomeric material such as ethylene vinyl acetate(EVA), thermoplastic elastomer (TPE), or silicone, to allow motion ofthe inner walls and provide a greater jet coverage area with minimalmechanics, reducing the volumetric flow requirements to achieveoptimized performance, while providing a softer and more flexiblematerial to protect the teeth if direct contact with the teeth is made.A flexible membrane may also provide acceptable fitment over a largerange of users, due to its ability to conform to the teeth.Alternatively, the LCCM could be made of a rigid or semi-rigid material,such as but not limited to a thermoplastic.

In an alternate embodiment, the LCCM could also include abrasiveelements such as filaments, textures, polishing elements, additives(silica, etc.), and other geometric elements that could be used forother cleaning and/or treatment requirements as well as ensuring minimaldistance between the teeth and LCCM for, but not limited to, treatment,cleaning, and positioning.

The LCCM could be created via a variety of methods such as, but notlimited to, machining, injection molding, blow molding, extrusion,compression molding, and/or vacuum forming. It can also be created inconjunction with the manifold, but incorporating the manifold circuitrywithin the LCC, and/or over-molded onto the manifold to provide aunitary construction with minimal assembly.

In one embodiment, the LCCM may be fabricated separately and thenassembled to the manifolds, utilizing any number of assembling andsealing techniques, including adhesives, epoxies, silicones, heatsealing, ultrasonic welding, and hot glue. The LCCM is designed in a waythat, when assembled with the manifold, it effectively and efficientlycreates the preferred dual manifold design without any additionalcomponents.

In certain embodiments, the LCCM can also be designed or used to createthe gingival sealing area. In certain embodiments, a vacuum is appliedwithin the LCC, which improves the engagement of the mouthpiece to forma positive seal with the gingival in the oral cavity. In otherembodiments, a pressure is applied outside the LCCM, within the oralcavity, which improves the engagement of the mouthpiece to form apositive seal with the gingival in the oral cavity. In yet otherembodiments, a denture-like adhesive may be applied around themouthpiece during the initial use to provide a custom reusable resilientseal when inserted into the oral cavity for a particular user. It wouldthen become resiliently rigid to both conform and provide a positiveseal with the guns and on subsequent applications. In anotherembodiment, the seal could be applied and/or replaced or disposed ofafter each use.

The directing means also comprise a first manifold for containing theliquid and for providing the liquid to the LCC through the openings ofthe front inner wall, and a second manifold for containing the liquidand for providing the liquid to the chamber through the openings of therear inner wall. This design provides a number of different options,depending on what operation is being conducted. For instance, in acleaning operation, it may be preferable to deliver jets of liquid intothe LCC directly onto the teeth from one side of the LCC from the firstmanifold and then evacuate/pull the liquid around the teeth from theother side of the LCC into the second manifold to provide controlledinterdental, gumline and surface cleaning. This flow from the one sideof the LCC could be repeated a number of times in a pulsing actionbefore reversing the flow to deliver jets of liquid from the secondmanifold and evacuating/pulling the liquid through the back side of theteeth into the first manifold for a period of time and/or number ofcycles. Such liquid action creates a turbulent, repeatable andreversible flow, thus providing reciprocation of the liquid about thesurfaces of the oral cavity.

In alternate embodiments, the manifold can be of single manifold designproviding pushing and pulling of the liquid through the same sets ofjets simultaneously, or can be any number of manifold divisions toprovide even greater control of the liquid delivery and removal of thecleaning and liquid treatment. In the multi-manifold also can bedesigned to have dedicated delivery and removal manifolds. The manifoldscan also be designed to be integral to and/or within the LCCM.

The material for the manifold would be a semi-rigid thermoplastic, whichwould provide the rigidity necessary not to collapse or burst during thecontrolled flow of the liquids, but to provide some flexibility whenfitting within the user's mouth for mouthpiece insertion,sealing/position and removal. To minimize fabrication complexity, numberof components and tooling cost, the dual manifold is created whenassembled with the LCCM. The manifold could also be multi-component toprovide a softer external “feel” to the teeth/gums utilizing a lowerdurometer elastomeric material, such as, but not limited to, acompatible thermoplastic elastomer (TPE). The manifold could be createdvia a variety of methods such as, but not limited to machining,injection molding, blow molding, compression molding, or vacuum forming.

The directing means also comprises a first port for conveying the liquidto and from the first manifold and a second port for conveying theliquid to and from the second manifold, and means for providing aneffective seal of the directing means within the oral cavity, i.e. agingival seal. In certain embodiments, the first and second ports mayserve both to convey liquid to and from the first and second manifoldsand to attach the mouthpiece to the means for providing liquid to themouthpiece. In other embodiments, the directing means may furtherinclude means for attaching the directing means to means for providingliquid to the directing means.

FIG. 1 is a schematic drawing of an embodiment of a system utilized inmethods according to the present invention. The figure shows system 200,with components including: means for providing reciprocation of liquidin the oral cavity 202, means for directing the liquid onto theplurality of surfaces of the oral cavity, in this instance shown asapplication tray 100, and liquid supply reservoir 290. Means forproviding reciprocation of liquids may include, in this embodiment,delivery/collection device 210, reciprocating flow controller 230, tubes212, 216, and 292 for conveying the liquid throughout the system, andliquid one-way flow valves 214, 218 and 294. Tubes 232 and 234 providefor conveyance of the liquid from reciprocating flow controller 230 toapplication tray 100.

In some embodiments, delivery/collection device 210 may be a pistonpump. Liquid supply reservoir 290 may be made of glass, plastic ormetal. Liquid supply reservoir 290 may be integral to system 200 andrefillable. In some embodiments, liquid supply reservoir 290 may be areplaceable liquid supply, such as a single or multi-use cartridge,detachably connected to system 200.

In some embodiments, liquid supply reservoir 290 and/or tubes 212, 292,may include a heat source to pre-warm the liquid prior to direction intoapplication tray 100 for application to the surfaces of the oral cavity.The temperature should be maintained within a range effective to provideefficacy and comfort to the user during use.

Application tray 100, discussed in detail herein below, could beintegral with, or detachably connected to reciprocating means 202 by wayof tubes 232, 234 and further attachment means (not shown). It could beone or two sided with internally, easily cleanable filters for trappingfood particles. When positioned within the oral cavity, e.g. about theteeth and gums, tray 100 forms an effective fit or seal against thegums, and includes means to direct liquid against surfaces of the oralcavity, e.g. surfaces of the teeth.

Liquid in liquid supply reservoir 290 flows through tube 292 todelivery/collection device 210. Liquid flow through tube 292 iscontrolled by one-way flow valve 294. From delivery/collection device210, liquid flows through tube 212 to reciprocating flow controller 230.One-way flow valve 214 controls the liquid flow through tube 212. Liquidflows from reciprocating flow controller 230 to application tray 100either through tube 232 or 234, depending on the flow direction settingof flow controller 230. Liquid flows from application tray 100, througheither tube 234 or 232 back to reciprocating flow controller 230, andfrom reciprocating flow controller 230 to delivery/collection device210, through tube 216. One-way flow valve 218 controls the liquid flowthrough tube 216.

The actions of delivery/collection device 210 may be controlled by alogic circuit, which may include a program to start the reciprocationcycle, a program to execute the reciprocation cycle, i.e. to causeliquid to be reciprocated about the teeth, thereby providing thebeneficial effect to the oral cavity, e.g. cleaning the teeth, a programto empty application tray 100 at the end of the reciprocation cycle, anda self-cleaning cycle to clean the system between uses, or at pre-set orautomatic cleaning times.

Though not shown, a face panel with a series of switches and indicatorlights may also be incorporated into system 200. Switches may include,but are not limited to, on/off, fill application tray 100, run thereciprocation program, empty system 200, and clean system 200.Indicator, or display, lights include, but are not limited to, power on,charging, reciprocation program running, system emptying, cleaningresults or feedback, and self-cleaning cycle in operation. Inembodiments where liquid is pre-warmed prior to direction intoapplication tray 100, a display light could be used to indicate that theliquid is at the proper temperature for use.

One method of using system 200 to clean teeth is as follows. In thefirst step, the user positions application tray 100 in the oral cavityabout the teeth and gingival area. The user closes down on tray 100,thereby achieving an effective fit or seal between gums, teeth and tray100. In use of the system according to the invention, the user pushes astart button initiating the cleaning process. The cleaning process is asfollows:

-   1. Delivery/collection device 210 is activated to begin drawing    cleaning liquid from liquid supply reservoir 290 through tube 292    and one-way valve 294.-   2. Once delivery/collection device 210 is sufficiently filled,    delivery/collection device 210 is activated to begin dispensing    cleaning liquid to application tray 100 via tube 212, one-way valve    214, reciprocating flow controller 230, and tube 232. Cleaning    liquid will be prevented from flowing through tubes 216 and 292 by    one-way flow valves 218 and 294, respectively.-   3. Delivery/collection device 210 is activated to begin drawing    cleaning liquid from application tray 100 through tube 234, then    through reciprocation flow controller 230, then through tube 216 and    one-way valve 218. Cleaning liquid will be prevented from flowing    through tube 212 by one-way flow valve 214. If there is insufficient    cleaning liquid to adequately fill delivery/collection device 210,    additional cleaning liquid may be drawn from liquid supply reservoir    290 through tube 292 and one-way valve 294.-   4. The direction of the liquid flow is then reversed.-   5. To reciprocate the cleaning liquid, steps 2 and 3 are repeated    after the flow direction is reversed, cycling cleaning liquid    between delivery/collection device 210 and application tray 100,    using tubes 234 and 232, respectively.-   6. The reciprocation cycle described continues until the time    required for cleaning has expired, or the desired numbers of cycles    are complete.

It is noted that there may be a delay between steps 2 and 3 (in eitheror both, directions), allowing a dwell time where the liquid is allowedto contact the teeth without flow.

FIG. 2 is a schematic drawing of a first alternative embodiment of asystem utilized in methods according to the present invention. Thefigure shows system 300, with components including: means for providingreciprocation of liquid in the oral cavity 302, liquid reservoir 370,liquid supply reservoir 390, and means for directing liquid onto andabout the plurality of surfaces in the oral cavity, in this instanceshown as application tray 100. Means for providing reciprocation offluids may include delivery device 310, collection device 320,reciprocating flow controller 330, tubes 312, 322, 372, 376, and 392,and solution one-way flow valves 314, 324, 374, 378, and 394. Tubes 332and 334 provide for conveyance of the liquid from reciprocating flowcontroller 330 to application tray 100.

In some embodiments, delivery device 310 and collection device 320 maybe individual, single action piston pump. In other embodiments, deliverydevice 310 and collection device 320 may be housed together as a dualaction piston pump. Liquid supply reservoir 390 and liquid reservoir 370may be made of glass, plastic or metal. Liquid supply reservoir 390 maybe integral to system 300 and refillable. In some embodiments, liquidsupply reservoir 390 may be a replaceable liquid supply, detachablyconnected to system 300.

In some embodiments, any of liquid supply reservoir 390, liquidreservoir 370, or tubes 312, 372, 392, may include a heat source topre-warm liquid prior to direction into application tray 100 forapplication to the plurality of surfaces in the oral cavity. Thetemperature should be maintained within a range effective to providecomfort to the user during use.

Application tray 100, could be integral with, or detachably connected tocleaning reciprocating means 302 by way of tubes 332, 334, and otherattachment means (not shown).

Liquid in liquid supply reservoir 390 flows through tube 392 to liquidreservoir 370. Liquid in reservoir 370 flows through tube 372 todelivery device 310. Liquid flow through tube 372 may be controlled byone-way flow valve 374. From delivery device 310, liquid flows throughtube 312 to reciprocating flow controller 330. One-way flow valve 314controls the liquid flow through tube 312. Liquid flows fromreciprocating flow controller 330 to application tray 100 through tube332 or 334, depending on the flow direction setting of flow controller330. Liquid flows from application tray 100, through tube 334 or 332back to reciprocating flow controller 330, and from reciprocating flowcontroller 330 to collection device 320, through tube 322. One-way flowvalve 324 controls the liquid flow through tube 322. Finally, cleaningliquid flows from collection device 320 to liquid reservoir 370 throughtube 376. One-way flow valve 378 controls the liquid flow through tube376.

The actions of delivery device 310 and collection device 320 arecontrolled by a logic circuit, which may include a program to the startof the reciprocation cycle, a program to execute the reciprocationcycle, i.e. to cause solution to be reciprocated about the plurality ofsurfaces of the oral cavity, thereby providing the beneficial effect, aprogram to empty application tray 100 at the end of the reciprocationcycle, and a self-cleaning cycle to clean the system between uses, or atpre-set or automatic cleaning times.

System 300 may also include switches such as on/off, fill applicationtray 100, run the cleaning program, empty system 300, and clean system300, and indicator, or display, lights including, but are not limitedto, power on, charging, cycle program running, device emptying, resultsor feedback, and self-cleaning cycle in operation. In embodiments whereliquid is pre-warmed prior to direction into application tray 100, adisplay light could be used to indicate that the liquid is at the propertemperature for use.

One method of using system 300 to clean teeth is as follows. Prior touse, cleaning liquid in liquid supply chamber 390 flows through tube 392and one-way valve 394 to cleaning liquid reservoir 370. In someembodiments, liquid supply reservoir 390 is now disconnected from system300.

In the first step, the user positions application tray 100 in the oralcavity about the teeth and gingival area. The user closes down on tray100, thereby achieving an effective fit or seal between gums, teeth andtray 100. The user pushes a start button initiating the cleaningprocess. The cleaning process is as follows:

-   1. Delivery device 310 is activated to begin drawing cleaning liquid    from cleaning liquid reservoir 370 through tube 372 and one-way flow    valve 374.-   2. Once delivery device 310 is sufficiently filled, delivery device    310 is activated to begin dispensing cleaning liquid to application    tray 100 via tube 312, one-way valve 314, reciprocating flow    controller 330, and tube 332.-   3. Collection device 320 is activated sequentially to, or    simultaneously with, activation of delivery device 310 to begin    drawing cleaning liquid from application tray 100 via tube 334,    reciprocating flow controller 330, tube 322, and one-way valve 324.    Cleaning solution will be prevented from flowing through tube 372 by    one-way flow valve 374. In some embodiments, delivery device 310 and    collection device 320 are controlled by a logic circuit to work in    concert so that an equal volumetric flow of cleaning liquid is    dispensed from delivery device 310 and drawn into collection device    320.-   4. Collection device 320 is activated to begin dispensing cleaning    solution to cleaning liquid reservoir 370 via tube 376 and one-way    valve 378. Cleaning liquid will be prevented from flowing through    tube 322 by one-way flow valve 324. Delivery device 310 is also    activated to begin drawing cleaning liquid from cleaning liquid    reservoir 370 through tube 372 and one-way flow valve 374.-   5. To reciprocate the cleaning liquid, steps 2 and 3 are repeated    after the flow direction is reversed, cycling cleaning liquid    between delivery/collection device 320 and application tray 100,    using tubes 334 and 332, respectively.-   6. To cycle cleaning liquid, steps 2 through 4 are repeated, cycling    cleaning liquid between cleaning liquid reservoir 370 and    application tray 100.-   7. The process continues to run until the time required for cleaning    has expired, or the desired numbers of cycles are complete.

FIG. 3 is a schematic drawing of a second alternative embodiment of asystem utilized in methods according to the present invention. Thefigure shows system 400, with components including: means for providingreciprocation of liquids in the oral cavity 402, liquid reservoir 470,liquid supply reservoir 490, and means for directing the liquid onto theplurality of surfaces of the oral cavity, in this instance shown asapplication tray 100. Means for providing reciprocation 402 may includedelivery device 410, collection device 420, reciprocating flowcontroller 430, tubes 412, 422 a, 422 b, 472, 476, and 492, and solutionone-way flow valves 414, 424 a, 424 b, 474, 478 a, 478 b, and 494. Tubes432 and 434 provide for conveyance of the liquid from reciprocating flowcontroller 430 to application tray 100.

In the present embodiment, delivery device 410 and collection device 420are housed together as a dual action piston pump, with common piston415. Liquid supply reservoir 490 and liquid reservoir 470 may be made ofglass, plastic, or metal. Liquid supply reservoir 490 may be integral tosystem 400 and refillable. In some embodiments, liquid supply chamber490 may be a replaceable liquid supply, detachably connected to system400.

In some embodiments, any of liquid supply chamber 490, liquid reservoir470, or tubes 412, 472, 492, may include a heat source to pre-warmcleaning solution prior to direction into application tray 100 forapplication to the teeth. The temperature should be maintained within arange effective to provide comfort to the user during use.

Application tray 100 could be integral with, or detachably connected toreciprocating means 402 by way of tubes 432, 434 and other attachmentmeans (not shown).

Liquid in liquid supply chamber 490 flows through tube 492 to liquidreservoir 470. Liquid in reservoir 470 flows through tube 472 todelivery device 410. Liquid flow through tube 472 is controlled byone-way flow valve 474. From delivery device 410, liquid flows throughtube 412 to reciprocating flow controller 430. One-way flow valve 414controls the liquid flow through tube 412. Liquid flows fromreciprocating flow controller 430 to application tray 100 through tube432 or tube 434, depending on the flow direction. Liquid flows fromapplication tray 100, through tube 434 or tube 432, again depending onthe flow direction, back to reciprocating flow controller 430, and fromreciprocating flow controller 430 to collection device 420, throughtubes 422 a and 422 b. One-way flow valves 424 a and 424 b control theliquid flow through the tubes. Finally, liquid flows from collectiondevice 420 to liquid reservoir 470 through tubes 476 a and 476 b.One-way flow valves 478 a and 478 b control the liquid flow through thetubes.

The actions of delivery device 410 and collection device 420 arecontrolled by a logic circuit, which may include a program to the startreciprocation cycle, a program to execute the reciprocation cycle, i.e.to cause solution to be reciprocated about the plurality of the surfacesof the oral cavity, thereby providing the beneficial effect, a programto empty application tray 100 at the end of the cycle, and aself-cleaning cycle to clean the system between uses, or at pre-set orautomatic cleaning times.

System 400 may also include switches such as on/off, fill applicationtray 100, execute cleaning process, empty system 400, and clean system400, and indicator, or display, lights including, but are not limitedto, power on, charging, reciprocation program running, device emptying,and self-cleaning cycle in operation. In embodiments where liquid ispre-warmed prior to direction into application tray 100, a display lightcould be used to indicate that the liquid is at the proper temperaturefor use.

One method of using system 400 to clean teeth is as follows. Prior touse, cleaning liquid in liquid supply reservoir 490 flows through tube492 and one-way valve 494 to cleaning liquid reservoir 470. In someembodiments, liquid supply reservoir 490 is now disconnected from system400.

In the first step, the user positions application tray 100 in the oralcavity about the teeth and gingival area. The user closes down on tray100, thereby achieving an effective fit or seal between gums, teeth andtray 100. The user pushes a start button initiating the cleaningprocess. The cleaning process is as follows:

-   1. Piston 415 is activated to begin drawing cleaning liquid to    delivery device 410 from cleaning liquid reservoir 470 through tube    472 and one-way flow valve 474. To accomplish this, piston 415    translates from right to left (“R” to “L” on FIG. 3).-   2. Once delivery device 410 is sufficiently filled, delivery device    410 is activated to begin dispensing cleaning liquid to application    tray 100 via tube 412, one-way valve 414, reciprocating flow    controller 430, and tube 432. To accomplish this, piston 415    translates from left to right (“L” to “R” on FIG. 3). The “L” to “R”    motion of piston 415 causes collection device 420 to begin drawing    cleaning liquid from application tray 100 via tube 434,    reciprocating flow controller 430, tube 422 a, and one-way valve    424 a. Cleaning liquid will be prevented from flowing through tubes    472 and 422 a, by one-way flow valves 474 and 424 b. Any excess    cleaning liquid in collection device 420 will begin dispensing to    cleaning liquid reservoir 470 via tube 476 b and one-way valve    478 b. Cleaning liquid will be prevented from flowing through tube    422 b by one-way flow valve 424 b.-   3. To cycle cleaning solution, steps 1 and 2 are repeated, cycling    cleaning liquid between cleaning solution reservoir 470 and    application tray 100.-   4. The process continues to run until the time required for cleaning    has expired, or the desired numbers of cycles are complete.

Each embodiment described in FIG. 1, FIG. 2, and FIG. 3 includesreciprocating flow controller (230, 330, 430 in FIG. 1, FIG. 2, FIG. 3,respectively). A perspective drawing and an exploded view of anembodiment of a reciprocating flow controller is shown in FIG. 6a andFIG. 6 b, respectively. The figures show reciprocating flow controller500 with housing 510 and flow diverter 520. Housing 510 has ports 514,515, 516, and 517. Flow diverter 520 occupies the space defined by theinner walls of housing 510, and has panel 522 for diverting liquid flow,and position adjuster 524.

FIG. 6c is a cross-sectional view of reciprocating flow controller 500in its first position. In this position, incoming liquid flow 532, suchas liquid in tube 212 of FIG. 1, enters reciprocating flow controller500 through port 515. The liquid exits reciprocating flow controller 500through port 514 as outgoing liquid flow 534, or as liquid in tube 232of FIG. 1. Returning liquid flow 536, such as liquid in tube 234 of FIG.1, reenters reciprocating flow controller 500 through port 517. Theliquid exits reciprocating flow controller 500 through port 516 asoutgoing liquid flow 538, or as liquid in tube 216 of FIG. 1.

FIG. 6d is a cross-sectional view of the reciprocating flow controller500 in its second position. In this position, incoming liquid flow 532,such as liquid in tube 212 of FIG. 1, enters reciprocating flowcontroller 500 through port 515. The liquid exits reciprocating flowcontroller 500 through port 516 as outgoing liquid flow 534, or asliquid in tube 234 of FIG. 1. Returning liquid flow 536, such as liquidin tube 232 of FIG. 1, reenters reciprocating flow controller 500through port 517. The liquid exits reciprocating flow controller 500through port 514 as outgoing liquid flow 538, or as liquid in tube 216of FIG. 1.

Reciprocation of liquid in application tray 100 of FIG. 1 is achieved byswitching reciprocating flow controller 500 between its first and secondpositions.

A perspective drawing of a first alternative embodiment of areciprocating flow controller is shown in FIG. 7 a. The figure showsreciprocating flow controller 550 with housing 560, flow control block570, and set pin 580. Housing 560 has ports 564, 565, 566, and 567. Flowcontrol block 570 occupies the space defined by the inner walls ofhousing 560, and has passages, or conduits, 571, 572, 573, and 574 fordiverting liquid flow.

FIG. 7b is a top view of reciprocating flow controller 550 in its firstposition (set pin 580 in “out” position). In first position, incomingliquid flow 592, such as liquid in tube 212 of FIG. 1, entersreciprocating flow controller 550 through port 564. The liquid flowsthrough passage 573 of control block 570, and exits reciprocating flowcontroller 550 through port 566 as outgoing liquid flow 594, or asliquid in tube 232 of FIG. 1. Returning liquid flow 596, such ascleaning liquid in tube 234 of FIG. 1, reenters reciprocating flowcontroller 550 through port 567. The liquid flows through passage 571 ofcontrol block 570, and exits reciprocating flow controller 550 throughport 565 as outgoing liquid flow 598, or as liquid in tube 216 of FIG.1.

FIG. 7c is a top view of reciprocating flow controller 550 in its secondposition (set pin 580 in “in” position). In second position, incomingliquid flow 592, such as liquid in tube 212 of FIG. 1, entersreciprocating flow controller 550 through port 564. The liquid flowsthrough passage 574 of control block 570, and exits reciprocating flowcontroller 550 through port 567 as outgoing liquid flow 594, or asliquid in tube 234 of FIG. 1. Returning liquid flow 596, such as liquidin tube 232 of FIG. 1, reenters reciprocating flow controller 550through port 566. The liquid flows through passage 572 of control block570, and exits reciprocating flow controller 550 through port 565 asoutgoing liquid flow 598, or as liquid in tube 212 of FIG. 1.

Reciprocation of liquid in application tray 100 of FIG. 1 is achieved byswitching reciprocating flow controller 550 between its first and secondpositions.

An exploded view, as well as a perspective view of a second alternativeembodiment of a reciprocating flow controller is shown in FIG. 8a andFIG. 8 b, respectively. The figures show reciprocating flow controller610 with housing 620 and flow control barrel 630. Housing 620 has ports621, 622, 623, and 624. Flow control barrel 630 occupies the spacedefined by the inner walls of housing 620, has passages 633, 634, 635,and 636 for diverting liquid flow, and position adjuster 632.

FIG. 8c is a side view of reciprocating flow controller 610 in its firstposition. In the first position, incoming liquid enters reciprocatingflow controller 610 through port 621. The liquid flows through passage634 of control barrel 630, and exits reciprocating flow controller 610through port 623. Returning liquid reenters reciprocating flowcontroller 610 through port 624. The liquid flows through passage 633 ofcontrol barrel 630, and exits reciprocating flow controller 610 throughport 622.

Though not shown, reciprocating flow controller 610 may be placed in itssecond position by rotating position adjuster 632 by 90°. In secondposition, incoming liquid enters reciprocating flow controller 610through port 621. The liquid flows through passage 636 of control barrel630, and exits reciprocating flow controller 610 through port 624.Returning liquid reenters reciprocating flow controller 610 through port623. The liquid flows through passage 636 of control barrel 630, andexits reciprocating flow controller 610 through port 622.

Reciprocation of liquid in application tray 100 of FIG. 1, 2 or 3 isachieved by switching reciprocating flow controller 610 between itsfirst and second positions.

A perspective drawing and an exploded view of a third alternateembodiment of a reciprocating flow controller is shown in FIG. 9a andFIG. 9 b, respectively. The figures show reciprocating flow controller710 with cap 720, flow diverter disk 730, and base 740. Cap 720 has capports 722 and 724. Base 740 has base ports 742 and 744. Flow diverterdisk 730 is disposed between cap 720 and base 740, and has panel 735 fordiverting liquid flow, and position adjuster 732 in the form of a gear.

FIG. 9c is a top view of reciprocating flow controller 710 in its firstposition. In this position, incoming liquid, such as liquid in tube 212of FIG. 1, enters reciprocating flow controller 710 through base port742. The liquid exits reciprocating flow controller 710 through cap port722, such as liquid in tube 232 of FIG. 1. Returning liquid, such asliquid in tube 234 of FIG. 1, reenters reciprocating flow controller 710through cap port 724. The liquid exits reciprocating flow controller 710through base port 744, such as liquid in tube 216 of FIG. 1.

FIG. 9d is a top view of the reciprocating flow controller 710 in itssecond position. In this position, incoming liquid, such as liquid intube 212 of FIG. 1, enters reciprocating flow controller 710 throughbase port 742. The liquid exits reciprocating flow controller 710through cap port 724 such as liquid in tube 234 of FIG. 1. Returningliquid, such as liquid in tube 232 of FIG. 1, reenters reciprocatingflow controller 710 through cap port 722. The liquid exits reciprocatingflow controller 710 through base port 744, such as liquid in tube 216 ofFIG. 1.

Reciprocation of liquid in application tray 100 of FIG. 1 is achieved byswitching reciprocating flow controller 710 between its first and secondpositions. It has been found that the width of panel 735 relative to thediameters of cap ports 722 and 724 and base ports 742 and 744 iscritical to the performance of reciprocating flow controller 710. If thewidth of panel 735 is equal to or greater than any of the diameters,then one or more of cap ports 722 and 724 or base ports 742 and 744 maybe blocked, or isolated, during part of the reciprocation, resulting insuboptimal performance or device failure. A channel may be located inpanel 735 to avoid this condition.

A perspective drawing and a side view of a fourth alternate embodimentof a reciprocating flow controller is shown in FIG. 10a and FIG. 10 b,respectively. The figures show reciprocating flow controller 750 withcap 760, flow diverter 770, and base 780. Cap 760 has cap ports 762 and764. Base 780 has base top ports 781, 782, 784, and 785, as well as basebottom ports 783 and 786. Base top ports 781 and 782 merge to form basebottom port 783, while base top ports 784 and 785 merge to form basebottom port 786. Flow diverter 770 is disposed between cap 760 and base780, and has twin gears 770 a and 770 b for diverting liquid flow.

FIG. 10c is a top view of reciprocating flow controller 750 in its firstposition. In this position, incoming liquid, such as liquid in tube 212of FIG. 1, enters reciprocating flow controller 750 through base bottomport 783, while base top port 784 is blocked. Gear 770 a is set so thatthe liquid exits base 780 through base top port 781. The liquid exitsreciprocating flow controller 750 through cap port 762, such as liquidin tube 232 of FIG. 1. Returning liquid, such as liquid in tube 234 ofFIG. 1, reenters reciprocating flow controller 750 through cap port 764.Gear 770 b is set so that the liquid enters base 780 through base topport 785. The liquid exits reciprocating flow controller 750 throughbase port 786, such as liquid in tube 216 of FIG. 1.

FIG. 10d is a top view the reciprocating flow controller 750 in itssecond position. In this position, incoming liquid, such as liquid intube 212 of FIG. 1, enters reciprocating flow controller 750 throughbase port 783. Gear 770 b is set so that the liquid exits base 780through base top port 782, while base top port 785 is blocked. Theliquid exits reciprocating flow controller 710 through cap port 764 suchas liquid in tube 234 of FIG. 1. Returning liquid, such as liquid intube 232 of FIG. 1, reenters reciprocating flow controller 750 throughcap port 762. Gear 770 a is set so that the liquid enters base 780through base top port 784, while base top port 781 is blocked. Theliquid exits reciprocating flow controller 750 through base port 786,such as liquid in tube 216 of FIG. 1.

Reciprocation of liquid in application tray 100 of FIG. 1 is achieved byswitching reciprocating flow controller 750 between its first and secondpositions. When between the first and second positions, flow cross-overis allowed to eliminate blocked flow, which could result in sub-optimaloperation or device failure.

A perspective drawing of a fifth alternate embodiment of a reciprocatingflow controller is shown in FIG. 11 a. The figure shows reciprocatingflow controller 810 with flow channels 831, 832, 833, 834, 835, 836,837, and 838, and flow diverter 820. Flow channel 831 splits to formflow channels 832 and 833. Flow channel 834 splits to form flow channels835 and 836. Flow channels 833 and 836 merge to form flow channel 837,flow channels 832 and 835 merge to form flow channel 838. Flow diverter820 is disposed adjacent to flow channels 831, 832, 833, 834, 835, 836,837, and 838, and has rod 822, driver 824, and flow control elements825, 826, 827, and 828 for diverting liquid flow.

FIG. 11b is a top view of reciprocating flow controller 810 in its firstposition. Driver 824 is set so that flow control elements 825 and 828prevent flow of liquid through channels 833 and 835, respectively, whileflow control elements 826 and 827 allow flow through channels 836 and832, respectively. In this position, incoming liquid, such as liquid intube 212 of FIG. 1, enters reciprocating flow controller 810 throughflow channel 831. Liquid flows through flow channel 832, and into flowchannel 838. The liquid exits reciprocating flow controller 810 throughflow channel 838, such as liquid in tube 232 of FIG. 1. Returningliquid, such as liquid in tube 234 of FIG. 1, reenters reciprocatingflow controller 810 through liquid channel 837. Liquid flows throughflow channel 836, and into flow channel 834, exiting reciprocating flowcontroller 810 through flow channel 834, such as liquid in tube 216 ofFIG. 1.

FIG. 11c is a top view of reciprocating flow controller 810 in itssecond position. Driver 824 is set so that flow control elements 826 and827 prevent flow of liquid through channels 836 and 832, respectively,while flow control elements 828 and 825 allow flow through channels 833and 835, respectively. In this position, incoming liquid, such as liquidin tube 212 of FIG. 1, enters reciprocating flow controller 810 throughflow channel 831. Liquid flows through flow channel 833, and into flowchannel 837. The liquid exits reciprocating flow controller 810 throughflow channel 837, such as liquid in tube 234 of FIG. 1. Returningliquid, such as liquid in tube 232 of FIG. 1, reenters reciprocatingflow controller 810 through liquid channel 838. Liquid flows throughflow channel 835, and into flow channel 834, exiting reciprocating flowcontroller 810 through flow channel 834, such as liquid in tube 216 ofFIG. 1.

Reciprocation of cleaning liquid in application tray 100 of FIG. 1 isachieved by switching reciprocating flow controller 810 between itsfirst and second positions.

FIG. 4 is a schematic drawing of another alternative embodiment of asystem utilized in methods according to the present invention. As shown,system 10 includes means for directing fluid onto a plurality ofsurfaces of an oral cavity, in this case shown as application tray 100,and contained within housing 12, piston pump 20 with piston 22 engagedwith a location sensor 24, logic circuit 30, energy supply 32, liquidsupply reservoir 40, liquid retention reservoir 42, tubes 52, 54, 56,58, liquid flow valves 62, 64, 66, 68, and pressure transducers 72, 74.

Housing 12 is capable of holding necessary components and is a means forholding necessary connectors. In embodiments where system 10 is sized tobe hand-held, housing 12 mates with an electrical charging base station,both mechanically and electrically.

In the embodiment shown, pump 20 is shown in the form of a double actingpiston pump, though it is conceived that a pair of single acting pumps,or other pump equivalents can be used. When the pump is a double actingpiston pump, the pump includes piston 22, first chamber 26, and secondchamber 28. Piston 22 is engaged with a location sensor 24. Pressuretransducers 72, 74 measure the pressure in first chamber 26 and secondchamber 28, respectively.

Liquid supply reservoir 40 and liquid retention reservoir 42 may be madeof glass, plastic, or metal. Supply reservoir 40 may be integral tohousing 12 and refillable. In some embodiments, supply chamber 40 may bea replaceable solution supply, detachably connected to housing 12.Retention reservoir 42 is used to store spent solution at the end of thecycle, e.g. cleaning cycle. Retention reservoir 42 also may include aport or other means, not shown, for discharging spent solution.

As will be discussed below, tubes 52, 54, 56, 58, and liquid flow valves62, 64, 66, 68 connect pump 20, liquid supply chamber 40, liquidretention reservoir 42, and application tray 100.

In some embodiments, supply reservoir 40 and/or tubes 52, 54, mayinclude a heat source to pre-warm liquid prior to direction intoapplication tray 100 for application to plurality of surfaces in theoral cavity. The temperature should be maintained within a rangeeffective to provide comfort to the user during use.

Energy supply 32 could be electrical, or in the form of replaceable orrechargeable batteries.

Application tray 100 could be integral with, or detachably connected tohousing 12 by way of tubes 54, 56 and other attachment means (notshown). It could be one or two sided with internally, easily cleanablefilters for trapping food particles. Furthermore, when applied to teeth,tray 100 will form an effective fit or seal against the gums, andincludes means to direct liquid against surfaces of the oral cavity.

In use, liquid in supply reservoir 40 flows through first tube 52 tofirst chamber 26 of pump 20. Liquid flow through first tube 52 iscontrolled by first valve 62. From first chamber 26 of pump 20, liquidflows through second tube 54 to application tray 100. Second valve 64controls the liquid flow through second tube 54. Liquid flows fromapplication tray 100, through third tube 56, to second chamber 28 ofpump 20, and is controlled by third valve 66. Second chamber 28 of pump20 is connected to retention reservoir 42 by fourth tube 58. The flow ofliquid through fourth tube 58 is controlled by fourth valve 68.

Logic circuit 30 may include a program to cause application tray 100 tobe filled with liquid at the start of the cycle, a program to executethe cycle, i.e. to cause liquid to be reciprocated about the pluralityof surfaces of the oral cavity, e.g. teeth and gingival area, therebyproviding the beneficial effect, e.g. cleaning the teeth, a program toempty application tray 100 at the end of the cycle, and a self-cleaningcycle to clean the system between uses, or at pre-set or automaticcleaning times. Logic circuit 30 includes means to detect liquidleakage, as well as means to make-up for leakage so as to maintain arelatively constant volume of liquid during the cycle. In the embodimentshown in FIG. 4, the means to detect liquid leakage uses pressuretransducers 72, 74 located in first chamber 26 and second chamber 28,respectively.

Though not shown, a face panel with a series of switches and indicatorlights may also be incorporated into system 10. Switches may include,but are not limited to, on/off, fill application tray 100, run thereciprocation program, empty system 10, and clean system 10. Indicator,or display, lights include, but are not limited to power on, charging,reciprocation program running, system emptying, cleaning results orfeedback and self-cleaning cycle in operation. In embodiments wherecleaning solution is pre-warmed prior to direction into application tray100, a display light could be used to indicate that the liquid is at theproper temperature for use.

One method of using system 10 to clean teeth is as follows. In the firststep, the user positions application tray 100 in the oral cavity aboutthe teeth and gingival area. The user applies pressure by closing downon tray 100, thereby achieving an effective seal between gums, teeth andtray 100. The user pushes a start button initiating loading of cleaningsolution into the space between the surface of tray 100 and the teeth tobe cleaned. Logic circuit 30 controls the cleaning process as follows:

-   1. First valve 62 opens, second valve 64 closes, piston 22 moves to    its left most position drawing liquid from supply reservoir 40    through first tube 52 into first chamber 26 of pump 20.-   2. First valve 62 closes, while second 64, third 66, and fourth 68    valves open. Piston 22 moves to its right most position, forcing    liquid through second tube 54 to application tray 100.-   3. To appropriately charge the system, steps 1 and 2 are repeated,    pumping liquid as above until a pre-determined pressure is detected    in both pressure transducers 72, 74, indicating that an appropriate    amount of liquid is contained within chambers 26 and 28. Chambers 26    and 28 may be completely or partially filled, so long as the amount    is effective to maintain reciprocating movement of the liquid    through the application tray and about the plurality of surfaces of    the oral cavity during use.-   4. First valve 62 and fourth valve 68 close, while second valve 64    and third valve 66 remain open.-   5. Piston 22 cycles from its left to right positions and back,    forcing liquid to be cycled back and forth across the surfaces, e.g.    teeth, in application tray 100.-   6. If a loss of pressure is detected by either pressure transducer    72, or 74, steps 1 to 3 are repeated to maintain the appropriate    volume of liquid in first chamber 26 and second chamber 28 of pump    20.-   7. The process continues to run until the time required for    achieving the beneficial effect, e.g. cleaning, has expired, the    cycles are complete, or the system has cycled a number of times    without pressure building-up, indicating that the liquid supply has    been exhausted.

In embodiments where liquid is pre-warmed prior to entry intoapplication tray 100, a temperature sensor is incorporated in thecircuit to warn the user that the solution is too cold to use, and amethod of heating the solution is provided.

In some embodiments, multiple liquid supplies may be utilized as shownin FIG. 5. The figure shows only the liquid supply portion of system 10(FIG. 4). Logic circuit 30 controls the process as follows:

-   1. First valve 62 a opens, valves 62 b, 62 c, and second valve 64    close, piston 22 moves to its left most position drawing liquid from    supply reservoir 40 a through tubes 52 a and 52 into first chamber    26 of pump 20.-   2. First valve 62 a closes, while second 64, third 66, and fourth 68    valves open. Piston 22 moves to its right most position forcing    liquid through second tube 54 to application tray 100.-   3. To fully charge the system, steps 1 and 2 are repeated, pumping    liquid until pressure is detected in both pressure transducers 72,    74.-   4. First valve 62 and fourth valve 68 close, while second valve 64    and third valve 66 remain open.-   5. Piston 22 cycles from its left to right most positions, forcing    liquid to be cycled back and forth across the surfaces of the oral    cavity in application tray 100.-   6. If pressure is lost in either pressure transducer 72, 74, steps 1    to 3 are repeated, recharging the system when pressure is built back    up in first chamber 26 and second chamber 28 of pump 20.-   7. The process runs until the time is up, the cycles are complete,    or the system has cycled a number of times without pressure building    up indicating that the liquid has been used up.-   8. First valve 62 a closes, valve 62 b opens, valve 62 c remains    closed, and steps 1 to 7 are repeated with liquid in supply    reservoir 40 b.-   9. First valve 62 a remains closed, valve 62 b closes, valve 62 c    opens, and steps 1 to 7 are repeated with cleaning solution in    liquid supply reservoir 40 c.

It is important to note that this sequence can be repeated indefinitelywith additional supplies of liquid in the respective supply reservoirs.In addition, the final liquid supply reservoir may contain water orother cleaning liquids and the system may be purged for cleaning.

The oral hygiene system may be comprised of several major componentsincluding, but not limited to, a base station, a hand piece forcontaining means for providing reciprocation of liquid about theplurality of surfaces within the oral cavity, and the application tray,or mouthpiece. The system is suitable for in-home use and adapted todirect liquid onto a plurality of surfaces of a tooth simultaneously.The device cleans teeth and removes plaque using cleaning solution thatis reciprocated back and forth creating a cleaning cycle and minimizingcleaning solution used. The device could be hand held, or may be in theform of a table or counter-top device.

The base station will charge a rechargeable battery in the hand piece,hold liquid reservoirs, house diagnostic components, provide feedback tothe user, and potentially clean the mouthpiece.

The hand piece will have a powered pump that will deliver liquid fromthe reservoir to the mouthpiece. The direction of flow may bereciprocated with liquid control valving, by a specialized pump(reversing its direction, etc), reversible check valves, or othersimilar means. The cycle time and flow velocity for each stage of thecycle will be variable and in some embodiments, be customized to eachindividual user. The hand piece will perform a filling process, and acleaning and/or purging process. The hand piece and/or base station mayprovide feedback to the user for each stage of the process andpotentially report diagnostic information.

The hand piece will be aesthetically pleasing and have a grip/feelcomfortable for the user's hand. The weight and balance will be wellsuited to comfortable and efficient use while giving a high qualityfeel. Finger grips and/or touch points will be appropriately located forcomfort, grip, feel, and assistance in proper orientation and griplocation of the hand piece. The base station will also be aestheticallypleasing and allow the hand piece to easily and securely dock intoposition. The base station may or may not lock the hand piece intoposition once it's docked.

The third major component of the apparatus is the application tray, ormouthpiece.

FIG. 12 is a top perspective view of a first embodiment of means fordirecting liquid onto a plurality of surfaces in the oral cavity, e.g.an application tray 100, utilized in methods according to the presentinvention. FIG. 13 is a bottom perspective view of the application tray100 of FIG. 12. The figures show application tray 100 with outer frontwall 112, outer back wall 114, inner front wall 116, inner back wall118, and base membrane, e.g. bite plate, 156. Inner front wall jet slots132 are located on inner front wall 116, while inner back wall jet slots134 are located on inner back wall 118. The inner front wall jet slots132 and inner back wall jet slots 134 shown in FIGS. 12 and 13 are onlyone embodiment of jet slot configuration. First port 142 and second port144 enter application tray 100 through outer front wall 112.

FIGS. 12 and 13 depict an embodiment of an application tray 100 in whichthe user's top and bottom teeth and/or gingival area are substantiallysimultaneously contacted with liquid to provide the desired beneficialeffect. It should be understood that in other embodiments, applicationtray 100 may be designed to clean and/or treat only the top or bottomteeth and/or gingival area of the user.

FIGS. 14 and 15 are vertical and horizontal, respectively, sectionalviews of the application tray 100 of FIG. 12. The figures show firstmanifold 146, defined as the space bordered by outer front wall 112 andinner front wall 116. Second manifold 148 is defined as the spacebordered by outer back wall 114 and inner back wall 118. Theliquid-contacting chamber (LCC) 154 is defined by inner front wall 116,inner back wall 118, and base membrane 156.

In one embodiment of an operation, liquid enters first manifold 146through first port 142 by pressure and then enters LCC 154 through innerfront wall jet slots 132. A vacuum is pulled on second port 144 to pullthe liquid through inner back wall jet slots 134, into second manifold148 and finally into second port 144. In this embodiment, jets of liquidare first directed onto the front surfaces of the teeth and/or gingivalarea from one side of the LCC 154, directed through, between, and aroundthe surfaces of the teeth and/or gingival area from the other side ofLCC 154 into the second manifold to provide controlled interdental,gumline, surface and/or gingival area cleaning or treatment. Next, theflow in the manifolds is reversed. Cleaning liquid enters secondmanifold 148 through second port 144 by pressure and then enters LCC 154through inner back wall jet slots 134. A vacuum is pulled on first port142 to pull the liquid through inner front wall jet slots 132, intofirst manifold 146 and finally into first port 142. In the secondportion of this embodiment, jets of liquid are directed onto the backsurfaces of the teeth and/or gingival area, and directed through,between, and around the surfaces of the teeth and/or gingival area. Thealternating of pressure/vacuum through a number of cycles creates aturbulent, repeatable and reversible flow to provide reciprocation ofliquid about the plurality of surfaces of the oral cavity tosubstantially simultaneously contact the surfaces of the oral cavitywith liquid, thereby providing the desired beneficial effect.

In another embodiment it may be preferable to deliver the liquid throughone or both manifolds simultaneously, flooding LCC 154, submerging theteeth for a period of time and then evacuating LCC 154 after a setperiod of time through one or both manifolds. Here, cleaning or treatingliquid simultaneously enters first manifold 146 through first port 142,and second manifold 148 through second port 144 by pressure and thenenters LCC 154 simultaneously through inner front wall jet slots 132 andinner back wall jet slots 134. To evacuate LCC 154, a vacuum issimultaneously pulled on first manifold 146 through first port 142, andsecond manifold 148 through second port 144. Cleaning or treatmentliquid is pulled through inner front wall jet slots 132 and inner backwall jet slots 134, into first manifold 146 and second manifold 148.

It is also possible to deliver different liquid compositions to firstmanifold 146 and second manifold 148. The different liquid compositionscould then combine in the LCC for improved cleaning efficacy ortreatment effects.

FIG. 16 is a top, rear perspective view of a second embodiment of anapplication tray 1100 utilized in methods according to the presentinvention. FIG. 17 is a top, front perspective view of the applicationtray 1100 of FIG. 16, while FIG. 18 is a top view of the applicationtray of FIG. 16. The figures show application tray 1100 with top piece1102, bottom piece 1104, first port 1142, second port 1144, and supportplate 1108 fixedly attached to the front of said application tray. Firstport 1142 and second port 1144 enter application tray 1100 and extendthrough support plate 1108.

Optional quick disconnect structures, e.g. barbs, 1110 are attached tosupport plate 1108, allowing application tray 1100 to be quickly andeasily attached to and then disconnected from means for providing liquidto the application tray, such as may be contained in housing 12 ofdevice 10, as shown in FIG. 4. The housing would include structureeffective to receive such quick disconnect barbs, or similar quickdisconnect structure, in attachable engagement, to detachably connectthe application tray to the housing. The quick disconnect option couldbe used to replace used or worn application trays, or to changeapplication trays for different users. In some embodiments, a singleuser may change application trays to change the flow characteristics fordifferent options, such as number of cleaning nozzles, nozzle velocity,spray pattern, and locations, coverage area, etc.

FIGS. 16 to 19 depict an embodiment of an application tray 1100 in whichthe user's top and bottom teeth and/or gingival area are substantiallysimultaneously contacted with liquid. It should be understood that inother embodiments, application tray 1100 may be designed to contact onlythe top or bottom teeth or gingival area of the user with liquid.

Top piece 1102 has front liquid lumens 1102 a, 1102 b, 1102 c, and 1102d, back liquid lumens 1102 e, 1102 f, and 1102 g, first manifold 1146,second manifold 1148, base membrane 1156, and back gum-sealing membrane1158. Front liquid lumens 1102 a, 1102 b, 1102 c, and 1102 d are allconnected by first manifold 1146, and optionally (as shown on FIGS. 16to 19), connected to each other along all, or part of, their length.Likewise, back liquid lumens 1102 e, 1102 f, and 1102 g, are allconnected by second manifold 1148, and optionally, connected to eachother along all, or part of, their length.

Bottom piece 1104, may be a mirror image of top piece 1102, and hasfront liquid lumens 1104 a, 1104 b, 1104 c, and 1104 d, back liquidlumens 1104 e, 1104 f, and 1104 g, first manifold 1146, second manifold1148, base membrane 1156, and back gum-sealing membrane 1158. Frontliquid lumens 1104 a, 1104 b, 1104 c, and 1104 d are all connected byfirst manifold 1146, and optionally (as shown on FIGS. 16 to 19),connected to each other along all, or part of, their length. Likewise,back liquid lumens 1104 e, 1104 f, and 1104 g, are all connected bysecond manifold 1148, and optionally, connected to each other along all,or part of, their length.

Though FIGS. 16 and 17 show top piece 1102 with four front liquid lumens(1102 a, 1102 b, 1102 c, and 1102 d) and three back liquid lumens (1102e, 1102 f, and 1102 g), top piece 1102 may also be formed with two,three, five, six, or even seven front or back liquid lumens. Likewise,bottom piece 1104 is shown with four front liquid lumens (1104 a, 1104b, 1104 c, and 1104 d) and three back liquid lumens (1104 e, 1104 f, and1104 g), bottom piece 1104 may also be formed with two, three, five,six, or even seven front or back liquid lumens.

The liquid-contacting chamber ((LCC) 1154 a, mentioned above, is locatedin top piece 1102, defined by front liquid lumens (1102 a, 1102 b, 1102c, and 1102 d), back liquid lumens (1102 e, 1102 f, and 1102 g), basemembrane 1156, and back gum-sealing membrane 1158. Though not shown,bottom piece 1104 also has a LCC 1154 b, defined by front liquid lumens(1104 a, 1104 b, 1104 c, and 1104 d), back liquid lumens (1104 e, 1104f, and 1104 g), base membrane 1156, and back gum-sealing membrane 1158.

The multi-lumen design provides bidirectional or dedicated lumens forflow and vacuum that are self-reinforcing and therefore do not collapseunder vacuum or rupture under pressure while in use, maximizing thestructural integrity, while minimizing the size of the overallapplication tray 1100 for user comfort during insertion, in-use, andupon removal. This decreased size also serves to provide an enhancedeffective seal of the application tray in the oral cavity.

If the multiple lumens (1102 a, 1102 b, 1102 c, 1102 d, 1102 e, 1102 f,1102 g, 1104 a, 1104 b, 1104 c, 1104 d, 1104 e, 1104 f, and 1104 g) areconnected as described above, they form a lumen hinge sections (1103 onFIG. 17). This may result in the multi-lumen design providingconformance in the X, Y and Z directions, due to the flexibility oflumen hinge sections 1103 between each lumen. This design allowseffective and feasible conformance to a variety of different users teethand gum topography, providing the effective gum sealing withoutirritating the gums and allowing dynamic positioning of the liquidcleaning jets around each of the teeth to obtain proximal andinterdental cleaning action. The multiple lumens are also attached tothe first manifold 1146 and second manifold 1148. This creates asecondary flexible joint providing two additional degrees of motion forthe adjusting to different bite architectures that may be encountered.

The back gum-sealing membrane 1158 proves a flexible and universalsealing mechanism to minimize leakage into the oral cavity whileredirecting flow onto and around teeth, to maximize treatment/cleaningarea to get to hard-to-reach-places (HTRP). The membrane can provide anelastic function across the lumen longitudinal axis to form around theteeth and gums.

Base membrane 1156 provides the flexibility required for effective fitor sealing within the oral cavity and allowing redirection and flow ofjets back towards the teeth and/or gingival surfaces.

Optionally, application tray 1100 could also include gum-sealingcomponent if required, which could be attached to the front liquidlumens 1102 a, 1102 b, 1104 a, and 1104 b, and back liquid lumens 1102 eand 1104 e (member furthest from teeth).

Optionally, frictional elements, such as filament tufts, could also beplaced or secured through any of the lumen hinge sections 1103 withoutsignificantly increasing the size of application tray 1100, or impactinguser comfort or liquid flow in the application tray 1100.

Inner front wall jet slots 1132 are located on inner front wall of toppiece 1102 and bottom piece 1104, while inner back wall jet slots 1134are located on inner back wall of top piece 1102 and bottom piece 1104.Though only one inner front wall jet slot 1132 and inner back wall jetslot 1134 are shown in FIGS. 13 to 16, the number, shape and size ofinner front wall jet slots 1132 and inner back wall jet slots 1134affect the cleaning of the teeth and gums, and can be designed to directjets of cleaning liquid in a variety of spray patterns. The inner frontwall jet slots 1132 and inner back wall jet slots 1134 shown in FIGS. 16to 19 are only one embodiment of jet slot configuration.

FIGS. 16 and 17 depict an embodiment of an application tray 1100 inwhich surfaces of the users top and bottom teeth and/or gingival areaare substantially simultaneously contacted by liquid to provide thedesired beneficial effect. It should be understood that, in otherembodiments, application tray 1100 may be designed to contact only thetop or bottom teeth and/or gingival area of the user.

FIG. 19 is a cut-away view of the application tray 1100 of FIG. 16. Thefigure shows first manifold 1146 and second manifold 1148. In oneembodiment of a cleaning operation, cleaning liquid is pumped throughfirst port 1142, and enters first manifold 1146 through first flowdiverter 1143. Liquid enters front liquid lumens 1102 a, 1102 b, 1102 c,1102 d, 1104 a, 1104 b, 1104 c and 1104 d through front liquid lumenports 1147. The cleaning liquid then enters LCCs 1154 a and 1154 bthrough inner front wall jet slots 1132. A vacuum is pulled on secondmanifold feeder 1144 to pull the cleaning liquid through inner back walljet slots 1134, into back liquid lumens 1102 e, 1102 f, 1102 g, 1104 e,1104 f, and 1104 g. The liquid enters second manifold 1148 through backliquid lumen ports 1149, then through second flow diverter 1145, andfinally into second manifold feeder 1144.

In this embodiment, jets of cleaning liquid are first directed fromfirst manifold 1146 to the front surfaces of the teeth and/or gingivalarea from one side of the LCCs, directed through, between, and aroundthe surfaces of the teeth and/or gingival area from the other side ofthe LCCs into the second manifold 1148 to provide controlledinterdental, gumline, surface and/or gingival area cleaning ortreatment.

Next, the flow in the manifolds is reversed. Cleaning liquid is pumpedthrough second port 1144, and enters second manifold 1148 through secondflow diverter 1145. Liquid enters back liquid lumens 1102 e, 1102 f,1102 g, 1104 e, 1104 f, and 1104 g through back liquid lumen ports 1149.The cleaning liquid then enters LCCs 1154 a and 1154 b through innerback wall jet slots 1134. A vacuum is pulled on first port 1142 to pullthe cleaning liquid through inner front wall jet slots 1132, into frontliquid lumens 1102 a, 1102 b, 1102 c, 1102 d, 1104 a, 1104 b, 1104 c and1104 d. The liquid enters first manifold 1146 through front liquid lumenports 1147, then through first flow diverter 1143, and finally intofirst port 1144.

In the second portion of this embodiment, jets of cleaning liquid aredirected onto the back surfaces of the teeth and/or gingival area, anddirected through, between, and around surfaces of the teeth and/orgingival area. The alternating of pressure/vacuum through a number ofcycles creates a turbulent, repeatable and reversible flow to providereciprocation of liquid about the plurality of surfaces of the oralcavity to substantially simultaneously contact the surfaces of the oralcavity with liquid, thereby providing the desired beneficial effect.

In another embodiment it may be preferable to deliver the liquid throughone or both manifolds simultaneously, flooding LLCs 1154 a and 1154 b,submerging the teeth for a period of time and then evacuating the LCCsafter a set period of time through one or both manifolds. Here, cleaningor treating liquid is simultaneously pumped through first port 1142 intofirst manifold 1146 via first flow diverter 1143, and through secondport 1144 into second manifold 1148 via second flow diverter 1145.Liquid then simultaneously enters front liquid lumens 1102 a, 1102 b,1102 c, 1102 d, 1104 a, 1104 b, 1104 c and 1104 d through front liquidlumen ports 1147, and back liquid lumens 1102 e, 1102 f, 1102 g, 1104 e,1104 f, and 1104g through back liquid lumen ports 1149. The cleaningliquid then enters LCCs 1154 a and 1154 b through inner front wall jetslots 1132 and inner back wall jet slots 1134. To evacuate the LCCs, avacuum is simultaneously pulled on first manifold 1146 through firstport 1142, and second manifold 1148 through second port 1144. Cleaningor treatment liquid is pulled through inner front wall jet slots 1132and inner back wall jet slots 1134, into first manifold 146 and secondmanifold 148.

It is also possible to deliver different liquid compositions to firstmanifold 1146 and second manifold 1148. The different liquidcompositions would then combine in the LCC for improved cleaningefficacy or treatment effects. In the dual manifold design it may bepreferable to supply each manifold from a separate liquid supplyreservoir, such as in a dual action piston pump configuration, where onesupply line connects to supply first manifold 1146 and the other pistonsupply line provides and removes liquid from second manifold 1148, e.g.when one manifold is being supplied with liquid the second manifold isremoving liquid, and vice versa.

In other embodiments, valves can be placed at front liquid lumen ports1147 of front liquid lumens 1102 a, 1102 b, 1102 c, 1102 d, 1104 a, 1104b, 1104 c and 1104 d, or at back liquid lumen ports 1149 of back liquidlumens 1102 e, 1102 f, 1102 g, 1104 e, 1104 f, and 1104 g to provideimproved function by allowing lumens to engage at different times (atdifferent points in the cleaning/treatment cycle), at pulsed intervals.As an example, in one embodiment, not all lumens engage in the liquidpumping/vacuum function. Here, front liquid lumens 1102 a and 1104 a,and back liquid lumens 1102 e and 1104 e, which primarily engage thegums, only engage in the liquid vacuum function. This would help preventliquid from leaking into the oral cavity. Valving also allows forvariable flow, allowing a decreased resistance to the liquid vacuumfunction, or allowing increased pumping, and therefore liquid velocity,during liquid delivery.

In still other embodiments, individual inner front wall jet slots 1132or inner back wall jet slots 1134 may have integrated one-way valves,such as duckbill valves or umbrella valves, to allow flow only in onedirection out of those particular jets. This may be effective toincrease vacuum relative to pressure/delivery in the LCC.

In some embodiments, the motion of the frictional elements discussedabove, relative to the teeth, could be applied by a single orcombination of mechanisms including, by not limited to, the liquid (viathe jet slots or via turbulence of flow); movement of the membrane viathe pulsing of the flexible application tray 1100; an externalvibrational mechanism to vibrate the frictional elements; linear and orrotational movement of the application tray 1100 around the teeththrough user jaw motion or external driving means.

In other embodiments, a conformable substance, such as gel, may bedisposed near the back gum-sealing membrane 1158, allowing applicationtray 1100 to comfortably fit against the back of the mouth.Alternatively, the end of application tray 1100 may have a mechanism orattachment to extend or decrease the length of the mouthpiece to theproper length for each individual user, providing a semi-custom fit.

Manufacturing of the multi-lumen design is feasible utilizing existingavailable manufacturing and assembly processes such as extrusion,injection, vacuum, blow, or compression molding. Other feasibletechniques include rapid prototyping techniques such as 3D printing andother additive techniques, as well as subtractive techniques.

The application tray may be custom manufactured for each individualuser, or customizable by the individual user prior to use. For custommanufacture of the application tray, vacuum form molds can be createddirectly or indirectly from user teeth and gingival impressions, whichcreate a model of the teeth which can then be modified to createrequired clearances and flow channels. These vacuum form molds can becreated at low cost utilizing CAD and rapid prototyping processes.

One manufacturing method is to create individual component shellsthrough vacuum forming. Low cost methods allow vacuuming forming of verythin wall structures. The component geometry is designed to provide theinterlocking features and structural geometry to allow minimization ofthe size of the application tray. When assembled, the manufacturedcomponents form the necessary manifolds and flow structure(bidirectional and/or dedicated manifolds) to provide the requiredperformance characteristics for treating/cleaning the teeth.

Customized mouthpieces are based on the user's teeth geometry, thereforecreating a consistent distance between the mouthpiece and teeth mayprovide a more consistent cleaning/treating experience. The materialsfor each of the two-piece shell may be different, therefore allowing forsofter material (on the inside shell) where it contacts teeth/gums andharder material on the outside shell to maintain rigidity and theoverall shape.

For customizable application trays, tray pre-forms (similar to sportmouth guards or teeth grinding appliances) containing pre-manufacturedmanifolds, nozzles and channels are mass manufactured. The traypre-forms can be created through a variety of known manufacturingtechniques including, but not limited to, blow molding, vacuum forming,injection and/or compression molding. The material used in the pre-formwould be a low temperature deformable plastic material. The pre-formwould be used in conjunction with required spacers to be applied overthe teeth to provide required clearance, cleaning and/or treatmentperformance. Once the clearance components are applied to the teeth, thepre-form would be heated via microwave or by placing in boiling water soas to be pliable. The pliable pre-form would be applied onto the user'steeth and gingival area to create the customized application tray.

The application tray can be integrated with stressing features to allowelastic conformance to maximize positioning, comfort and performanceduring application and in use. For example, spring-like elements such asshins, clips and elastic bands may provide fitting over and againstgums.

Materials for the MP lumen could range from lower durometer flexiblematerials (25 shore A) to harder materials more rigid materials (90shore A), preferably being between 40 and 70 shore A.

Materials could be silicone, thermoplastic elastomer (TPE),polypropylene (PP), polyethylene (PE), polyethylene terephthalate (PET),ethylene vinyl acetate (EVA), polyurethane (PU), or multi-component(combination of materials and hardness) to achieve desired design andperformance attributes.

The jet openings or slots could be made through a secondary operationsuch as drilling or punching, or formed during molding. Alternatively,the jet openings or slots could be inserted into the application tray toprovide increased wear and or different jet performance characteristics,and could be combined with frictional cleaning elements or othercomponents to enhance the cleaning and/or treatment affect.

FIGS. 20 to 23 depict an embodiment of an application tray 1200 in whichonly the user's top or bottom teeth and gingival area are contacted withliquid. It should be understood that in other embodiments, applicationtray 1200 may be designed to substantially simultaneously contact boththe top and bottom teeth and gingival area of the user, as depictedelsewhere herein.

FIG. 20 is a top front perspective view of a third embodiment of anapplication tray 1200 utilized in methods according to the presentinvention. FIG. 21 is a top back view of the embodiment of theapplication tray 1200 of FIG. 20, while FIG. 22 is a bottom back view ofthe application tray 1200 of FIG. 20. The figures show application tray1200 with outer front wall 1212, outer back wall 1214, inner front wall1216, and inner back wall 1218. Inner front wall jet slots 1232 arelocated on inner front wall 1216, while inner back wall jet slots 1234are located on inner back wall 1218. First port 1244 and second port1242 enter application tray 1200 through outer front wall 1212.

The number and location of inner front wall jet slot 1232 and inner backwall jet slot 1234 as shown in FIGS. 20 to 23 is exemplary and is notintended to limit the scope of the application tray. The actual number,shape and size of inner front wall jet slots 1232 and inner back walljet slots 1234 affect the cleaning of the teeth and gums, and can beselected or designed to direct jets of cleaning liquid in a variety ofspray patterns. The inner front wall jet slots 1232 and inner back walljet slots 1234 shown in FIGS. 20 to 22 are only one embodiment of jetslot configuration.

FIG. 23 is a vertical sectional view of the application tray 1200 ofFIG. 20. The figures show first manifold 1246, defined as the spacebordered by outer front wall 1212 and inner front wall 1216. Secondmanifold 1248 is defined as the space bordered by outer back wall 1214and inner back wall 1218. The liquid contact chamber (LCC) 1254 isdefined by inner front wall 1216, inner back wall 1218 and inner basewall 1250.

In one embodiment of a cleaning operation, cleaning liquid enters firstmanifold 1246 through first port 1244 by pressure and then enters LCC1254 through inner front wall jet slots 1232. A vacuum is pulled onsecond port 1242 to pull the cleaning liquid through inner back wall jetslots 1234, into second manifold 1248 and finally into second port 1242.In this embodiment, jets of cleaning liquid are first directed onto thefront side of the teeth from one side of the LCC, directed through,between, and around the teeth from the other side of the LCC into thesecond manifold to provide controlled interdental, gumline, surfaceand/or gingival area cleaning. Next, the flow in the manifolds isreversed. Cleaning liquid enters second manifold 1248 through secondport 1242 by pressure and then enters LCC 1254 through inner back walljet slots 1234. A vacuum is pulled on first port 1244 to pull thecleaning liquid through inner front wall jet slots 1232, into firstmanifold 1246 and finally into first port 1244. In the second portion ofthis embodiment, jets of cleaning liquid are directed onto the back sideof the teeth, and directed through, between, and around the teeth and/orgingival area. The alternating of pressure/vacuum through a number ofcycles creates a turbulent, repeatable and reversible flow, therebyproviding reciprocation of liquid over and about the surfaces of theoral cavity.

It is also possible to deliver different liquid compositions to firstmanifold 1246 and second manifold 1248. The different liquidcompositions would then combine in the LCC for improved cleaningefficacy. In the dual manifold design it may be preferable to supplyeach manifold from a separate chamber, such as in a dual action pistonpump configuration, where one supply line connects and to supply firstmanifold 1246 and the other piston supply line provides and removes fromsecond manifold 1248 (when one manifold is being supplied the secondmanifold is removing and vice versa).

An embodiment of a hand-held device utilized in methods according to thepresent invention is shown in FIGS. 24a to 24 e. FIG. 24a is an explodedview of a hand piece 3000 that pumps liquid to, and pulls liquid from,the application tray, thus providing reciprocation of the liquid to andfrom the application tray. In this embodiment, device 3000 is designedin a modular fashion, with a pumping section, a vacuum section, areciprocating section, and pumping and driving sections. Modularconstruction allows for easier design for manufacturing (DFM), with easyassembly and repair. The embodiment is also designed to minimize thesize of the device as well as the amount of liquid used in operation.

Device 3000 includes outlet pipes 3010 a and 3010 b, reciprocating flowcontroller 710, inlet disk top section 3050, inlet disk bottom section3090, delivery cylinder sleeve 3110 with bubble-break plate 3115 anddelivery cylinder filling tube 3112, separator plates 3210, 3310, vacuumend disks 3250, 3290, vacuum piston 3270, vacuum cylinder sleeve 3410,piston rod 3460, indexing shaft 3470, and diverter drive gear 3472.

An exploded view of pumping section of device 3000 is shown on FIG. 24b. The figure shows outlet pipes 3010 a, 3010 b attached to cap 720 ofreciprocating flow controller 710. Flow diverter disk 730, with positionadjuster 732 in the form of a gear, is disposed in cap 720 and sits onbase 740. O-ring 736 is between flow diverter disk 730 and base 740.Base ports 742 and 744 pass through base 740. Panel 735 for divertingliquid flow is disposed in flow diverter disk 730. Inlet disk topsection 3050 has inlet disk top section ports 3051, 3052, 3053, and3054, and is separated from base 740 by sealing gasket 3030. Inlet diskbottom section 3090 has inlet disk bottom section ports 3091, 3092,3095, 3096. Dual flap valve 3070 is between inlet disk top section 3050and inlet disk bottom section 3090, with the two flaps of dual flapvalve 3070 above inlet disk bottom section ports 3091 and 3092 and belowinlet disk top section ports 3052 and 3053. Inlet disk bottom sectionport 3091 includes a one-way valve 3093, allowing liquid to flow frominlet disk top section port 3052 to inlet disk bottom section port 3091through dual flap valve 3070. Inlet disk bottom section port 3092includes a one-way valve 3094, allowing liquid to flow from inlet diskbottom section port 3092 to inlet disk top section port 3053 throughdual flap valve 3070. Inlet disk bottom section 3090 is disposed on topof delivery cylinder sleeve 3110. Delivery is disposed along deliverycylinder sleeve 3110, while delivery piston 3130 is disposed in thevolume defined by delivery cylinder sleeve 3110. Bubble-break plate 3115is disposed about cylinder sleeve 3110. Delivery volume 3114 is thevolume defined by delivery cylinder sleeve 3110 minus the volume ofdelivery piston 3130.

FIG. 24c is an exploded view of vacuum section of device 3000. Thefigure shows separator plate 3210, with separator plate ports 3212 and3214, disposed on top of vacuum end disk 3250. Vacuum end disk 3250 hasvacuum end disk ports 3251 and 3252. Flap valves 3230 a and 3230 b arebetween separator plate 3210 and vacuum end disks 3250. Flap valves 3230a and 3230 b are above vacuum end disk ports 3251 and 3252 and belowseparator plate ports 3212 and 3214. Vacuum end disk port 3251 includesa one-way valve 3253, allowing liquid to flow from vacuum end disk port3251 to separator plate port 3214 through flap valve 3230 a. Vacuum enddisk port 3252 includes a one-way valve 3254, allowing liquid to flowfrom separator plate port 3212 to vacuum end disk port 3252 through fromflap valve 3230 b. Vacuum piston 3270, disposed under vacuum end disks3250, has piston rod hole 3272 through which piston rod 3460 passes.Beneath vacuum piston 3270 is vacuum end disk 3290, disposed on top ofseparator plate 3310. Vacuum end disk 3290 has vacuum end disk ports3291 and 3292. Separator plate 3310 has separator plate ports 3312 and3314. Flap valves 3230 c and 3230 d are between vacuum end disk 3290 andseparator plate 3310, above vacuum end disk ports 3291 and 3292 andbelow separator plate ports 3312 and 3314. Vacuum end disk port 3291includes a one-way valve 3293, allowing liquid to flow from vacuum enddisk ports 3291 towards separator plate port 3314 through flap valve3230 c. Vacuum end disk port 3292 includes a one-way valve 3294,allowing liquid to flow from separator plate port 3312 to vacuum enddisk port 3292 through flap valve 3230 d.

FIG. 24d is a side view of drive system of the pumping and drivingsections of device 3000. Motor 3420 drives shaft 3422, which is linkedto crankshaft arms 3430 a and 3430 b, and worm gear 3450. Crankshaftarms 3430 a and 3430 b are linked to crankshaft link arm 3435, which islinked to piston rod 3460. Piston rod 3460 is attached to vacuum piston3270 and, though not shown, delivery piston 3130. Indexing shaft 3470 isin contact with worm gear 3450, which is linked to diverter drive gear3472. When shaft 3412 spins, crankshaft arms 3430 a, 3430 b andcrankshaft link arm 3435 convert the rotary motion of shaft 3422 to alinear, reciprocating motion on piston rod 3460, such that vacuum piston3270 and delivery piston 3130 move up and down. Simultaneously, wormgear 3450 converts the rotary motion of shaft 3422 to a rotary motion ofindexing shaft 3470. Indexing shaft 3470 rotates diverter drive gear3472, which is linked to position adjuster 732 in reciprocating flowcontroller 710.

FIG. 24e is a cut-away view of device 3000, showing the spatialrelationships between the components in the pumping section, vacuumsection, and pumping and driving sections. Cylinder volume 3412 is thevolume of vacuum cylinder sleeve 3410 not occupied by the components ofthe pumping section, vacuum section, and pumping and driving sections,and serves as the liquid reservoir in the embodiment shown. The generaloperation of device 3000, is as follows:

-   1. Device 3000 is sufficiently filled with cleaning liquid. The    liquid initially resides in cylinder volume 3412 of vacuum cylinder    sleeve 3410.-   2. The user inserts any embodiment of an application tray, for    example application tray 100 or 1100, into their mouth. Device 3000    may be activated by a sensor (pressure sensor, proximity sensor,    etc.) or the device may be activated by the user. The cleaning cycle    is initiated.-   3. On the “down stroke” of piston rod 3460, delivery piston 3130    pulls liquid from the bottom of cylinder volume 3412. The liquid    flows through delivery cylinder filling tube 3112, inlet disk bottom    section port 3095, inlet disk top section port 3051, inlet disk top    section port 3052, dual flap valve 3070, and one-way valve 3093 in    inlet disk bottom section port 3091, and into delivery volume 3114.    It is preferred that the entry port 3116 on delivery cylinder    filling tube 3112 is located at the bottom of the tube to minimize    the total liquid required for cleaning/treatment and to avoid    pulling air into delivery volume 3114.-   4. On the “upstroke” of piston rod 3460, delivery piston 3130 forces    the liquid though inlet disk bottom section port 3092 with one-way    valve 3094. The liquid flows through dual flap valve 3070, through    inlet disk top section port 3053, and finally through base port 742    of reciprocating flow controller 710.-   5. Liquid flow through reciprocating flow controller 710 is    described earlier using FIG. 9c and FIG. 9 d. In brief, when    reciprocating flow controller 710 is in its first position (FIG. 9c    ), incoming liquid from inlet disk top section port 3053 enters    reciprocating flow controller 710 through base port 742. The liquid    exits reciprocating flow controller 710 through cap port 722,    flowing into outlet pipe 3010 b. Returning liquid, flowing in    through outlet pipe 3010 a, reenters reciprocating flow controller    710 through cap port 724. The liquid exits reciprocating flow    controller 710 through base port 744. When reciprocating flow    controller 710 is in its second position (FIG. 9d ), incoming liquid    from inlet disk top section port 3053 enters reciprocating flow    controller 710 through base port 742. The liquid exits reciprocating    flow controller 710 through cap port 724, flowing into outlet pipe    3010 a. Returning liquid, flowing in through outlet pipe 3010 b,    reenters reciprocating flow controller 710 through cap port 722. The    liquid re-exits reciprocating flow controller 710 through base port    744. Reciprocation of cleaning liquid in application tray 100 of    FIG. 1 is achieved by switching reciprocating flow controller 710    between its first and second positions. As shown in FIG. 24 d, the    switching of reciprocating flow controller 710 between its first and    second positions is achieved by worm gear 3450, which converts the    rotary motion of shaft 3422 to a rotary motion of indexing shaft    3470. Indexing shaft 3470 rotates diverter drive gear 3472, which is    linked to position adjuster 732 in reciprocating flow controller    710. Though shown as continually rotating in this embodiment, it is    to be understood that reciprocating flow controller 710 may be    driven via separate means, such as another motor. Also, the time    interval for switching reciprocating flow controller 710 between its    first and second positions may, in some embodiments be between about    1 and about 100 seconds, or between about 2 and about 10 seconds,    and may be varied over the course of the cleaning/treatment.-   6. In the present embodiment, the vacuum section of device 3000 is    effective during both the “upstroke” and “down stroke” of piston rod    3460. Vacuum piston 3270 is dual acting, and draws liquid from    application tray 100 on both the upstroke and down stroke of vacuum    piston 3270. The liquid flowing through base port 744 of    reciprocating flow controller 710 flows through inlet disk top    section port 3054 and continues through inlet disk bottom section    port 3096, arriving in vacuum return tube 3411. The liquid in vacuum    return tube 3411 is then drawn to vacuum volumes 3275 a or 3275 b.    Vacuum volume 3275 a is the volume between vacuum end disk 3250 and    vacuum piston 3270. Vacuum volume 3275 b is the volume between    vacuum end disk 3290 and vacuum piston 3270. During the “upstroke”    of piston rod 3460, the liquid in vacuum return tube 3411 is drawn    through separator plate port 3312, and flows through flap valve 3230    d, one-way valve 3294, and vacuum end disk port 3292, arriving in    vacuum volume 3275 b. During the “down stroke” of piston rod 3460,    the liquid in cylinder volume 3412 is drawn through separator plate    port 3212, and flows through flap valve 3230 b, one-way valve 3254,    and vacuum end disk port 3222, arriving in vacuum volume 3275 a. As    noted, the vacuum piston 3270 in this embodiment is dual acting,    drawing liquid from application tray 100 on both the upstroke and    down stroke of vacuum piston 3270. So, while vacuum volume 3275 b is    drawing in liquid from vacuum return tube 3411, the liquid in vacuum    volume 3275 a is being pumped into cylinder volume 3412. In    contrast, while vacuum volume 3275 a is drawing in liquid from    vacuum return tube 3411, the liquid in vacuum volume 3275 b is being    pumped into cylinder volume 3412. During the “upstroke” of piston    rod 3460, the liquid in vacuum volume 3275 a is pumped through    vacuum end disk port 3251, and flows through one-way valve 3253,    flap valve 3230 a, and separator plate port 3214, arriving in    cylinder volume 3412. During the “down stroke” of piston rod 3460,    the liquid in vacuum volume 3275 b is pumped through vacuum end disk    port 3291, and flows through one-way valve 3293, flap valve 3230 c,    and separator plate port 3314, arriving in cylinder volume 3412.-   7. The cycle continues with cycles comprising both “upstrokes” and    “down strokes” of piston rod 3460, with liquid motion through device    3000 as described in steps 3 through 6 above.

The ratio of the total volume of vacuum volumes 3275 a and 3275 b todelivery volume 3114 may be any range, such as 1:1, optionally about 3:1or greater, or about 4:1 or greater. Since delivery piston 3130 onlydelivers liquid on one “half” of the pumping/vacuuming cycle, whilevacuum piston 3270 works on both halves of the cycle, the ratio of thevolume of liquid delivered to application tray 100 to the volume ofliquid drawn from application tray 100 is 8:1 per cycle. The dual actingvacuum piston 3270 also provides vacuum during the half of the strokewhere delivery piston 3130 is not delivering liquid, increasing theopportunity to retrieve liquid from application tray 100, as well asclear additional liquid which leaked from application tray 100 into theoral cavity. Testing has shown a minimum 3:1 volumetric ratio of liquidvacuum to liquid delivery per stroke provided the necessary vacuum tominimize leakage into the oral cavity from application tray 100 when thetray has a marginal gingival seal, which may occur in embodiments of auniversal (designed to fit a range of people) application tray 100design.

In some embodiments vacuum piston 3270 is single acting. However, a dualacting vacuum piston 3270 may show some advantages.

In some embodiments, cylinder volume 3412 may have an air separator toreduce the foaming. Also, a breather vent may be required so that thepumping/vacuum system does not over pressurize and lock/fail. Thebreather vent may be on the opposite side of the cylinder volume 3412from the outlets of separator plate ports 3214 and 3314 to avoid liquidsplashing out of the breather vent. In addition there may be a wall tosplit the cylinder volume 3412 into two halves, to further reduce thechance of liquid splashing out of the breather vent.

In general, cylinder volume 3412 is vented since more liquid is beingdelivered to cylinder volume 3412 from the vacuum system than is beingdrawn from the delivery system. The excess (air) is exhausted from avent in cylinder volume 3412. The vent could use a valve, such as anumbrella valve, so air can escape but cannot enter the reservoir fromthe same opening, or a 2-way valve or vent hole. To further reduce lossof liquid through the vent, a wall may be used to divide cylinder volume3412 in two parts. One side contains the supply line, and the other sidecontains the vent. To optimize the separation of air from liquid incylinder volume 3412, an air separator may be placed in the reservoir,below the supply line. As the liquid drops from supply line intocylinder volume 3412, it passes through an air separator, which may be asolid plate with holes. This allows the liquid to pass, while removingentrained air and helping to separate the two liquid states (liquid vs.gas). The air separator may have various designs, such as an angledsolid shelf with holes, a spiraling ramp, a spiraling ramp with holes,two or more levels of angled shelves with holes, multiple spiralingramps, similar to a multiple starting points for threads, (bottle caps,etc), sporadically located bosses that the liquid hits as it drops,assisting in separation.

In one embodiment, the hand-held device will be a self-contained,portable unit with a rechargeable battery, have a motor-driven pistonpump for liquid delivery, have a mechanism to control the liquid flow,keep the temperature within a specified range, be modular in design, andhave ergonomics well-suited to the user's hand. When the hand piece isin the base station, it will recharge the battery, refill the liquidreservoirs in the hand piece from those in the base station, andexchange samples and/or diagnostic information with the base station. Itmay also go through a cleaning process.

FIGS. 25a-25d show a representation example of an embodiment of a dentalcleaning system 2000 utilized in methods according to the presentinvention. The figures show dental cleaning system 2000, showinghand-held device 2220, base station 2240, and base station liquidreservoir 2250. Base station liquid reservoir 2250 is used to refill theliquid reservoirs in device 2220. Application tray 2100 is shownattached to device 2220.

In this embodiment, base station liquid port 2245 is the conduit throughwhich cleaning or treatment liquid passes from base station liquidreservoir 2250 to the liquid reservoirs in device 2220. Liquid leavesbase station liquid reservoir 2250 through base station liquid reservoirport 2255, and enters the liquid reservoirs in device 2220 through port2225.

When in base station 2240, the internal battery of device 2220 willrecharge, and the liquid reservoirs in device 2220 will refill fromthose in base station 2240. Any diagnostic information in device 2220will be exchanged with base station 2240. Device 2220 may also gothrough a cleaning process.

In other embodiments, a piston pump with check-valves will be used forliquid delivery.

In yet other embodiments, a rotary piston pump will be used for liquiddelivery. This pump is known by those in the art, and the piston rotatesas it reciprocates, therefore not needing any valves to operate.Reversing the rotation direction of the drive motor will reverse theliquid flow direction.

In still other embodiments diaphragm pumps, gear pumps, or double-actionpiston pumps will be used for liquid delivery. In the case ofdouble-action piston pumps, when the liquid system is charged, this pumptype has the benefit of reciprocating the direction of the liquid flowto the mouthpiece. Charged pneumatic cylinders, hand pump, or rotarypumps may be used to drive the system.

EXAMPLE

A test was performed in which 4 subjects used devices accordingdescribed herein to assess efficacy of methods of the invention from agerm removal and kill perspective. One of the endpoint methods usedincluded bacterial viability determination via adenosine triphosphate(ATP) luminescence and total plate counts. Appropriate dilutions of thebaseline samples were made in 0.1% peptone water. Both the rinsate andpost-rinse samples were neutralized to stop antimicrobial actions andwere diluted PO₄ neutralizer. Mouthpieces substantially similar to thosedepicted in FIGS. 16-19 (universal mouthpiece) and FIGS. 20-23(custom-fit) were used in the test, one each of which was tested usingwater and the other with Cool Mint Listerine® mouth rinse (CML).

Total Cell Counts measuring colony forming units (CFU/ml), includingtotal viable bacterial cells and total viable bad breath organisms, wereused, respectively. The samples taken from the subjects were incubatedunder anaerobic conditions for 5 days at 35-37° C. The Relative LightUnits (RLU) is a measure of the amount of ATP in a sample. The higherthe RLU value, the more ATP is present, and the more live bacteria thereare. Total cell counts (CFU/ml) and RLU were determined for each sampletaken from the subjects both before (baseline) and post rinsing, as wellas on rinsates collected after rinsing.

The subjects rinsed the oral cavity with 5 mL water for 10 seconds. Thebaseline example was collected by having the subject expectorate therinse water into a conical tube, and then expectorating an additional 1ml of saliva into that tube. Each subject then rinsed the oral cavity, 2with water using the respective mouthpiece designs, and 2 with the CoolMint Listerine using the respective mouthpiece designs. The rinsate wasthen collected for each subject and 20 mL was placed in a conical tube.Each subject then repeated the rinse with 5 mL of water for 10 secondsand, as before, the rinse and the post-rinse sample collected in aconical tube. The samples were neutralized, diluted, plated and thenincubated for 5 days and the cell counts and ATP measured. Results arepresented in Tables 1-3. Subject 1 BL used water as the liquid and theuniversal mouthpiece. Subject 2 BL used water as the liquid and thecustom-fit mouthpiece. Subject 3 BL used CML as the liquid and theuniversal mouthpiece. Subject 4 BL used CML as the liquid and thecustom-fit mouthpiece.

TABLE 1 % Reduction Total Organisms Average Counts from baseline logreduction Subject 1 BL 1.88E+07 Subject 2 BL 2.07E+07 Subject 3 BL1.13E+08 Subject 4 BL 1.93E+08 Subject 1 Rinsate 7.40E+04 99.6% 2.40Subject 2 Rinsate 1.90E+04 99.9% 3.04 Subject 3 Rinsate 2.00E+03 100.0%4.75 Subject 4 Rinsate 3.00E+03 100.0% 4.81 Subject 1 Post 7.60E+0596.0% 1.40 Subject 2 Post 3.02E+06 85.4% 0.84 Subject 3 Post 8.70E+0692.3% 1.11 Subject 4 Post 7.20E+06 96.3% 1.43

TABLE 2 Bad Breath Organisms Average % Reduction log Counts frombaseline reduction Subject 1 BL 5.30E+06 Subject 2 BL 2.70E+06 Subject 3BL 2.10E+07 Subject 4 BL 3.50E+07 Subject 1 Rinsate 3.10E+04 99.4% 2.23Subject 2 Rinsate 1.00E+03 100.0%  3.43 Subject 3 Rinsate 1.50E+03100.0%  4.15 Subject 4 Rinsate 1.00E+03 100.0%  4.54 Subject 1 Post6.50E+05 87.7% 0.91 Subject 2 Post 4.40E+05 83.7% 0.79 Subject 3 Post2.80E+06 86.7% 0.88 Subject 4 Post 2.10E+06 94.0% 1.22

TABLE 3 ATP RLU % Reduction from baseline log reduction Subject 1 BL7.44E+04 Subject 2 BL 3.93E+04 Subject 3 BL 2.18E+05 Subject 4 BL3.12E+05 Subject 1 Rinsate 3.14E+04 57.7% 0.37 Subject 2 Rinsate2.85E+04 27.4% 0.14 Subject 3 Rinsate 2.81E+04 87.1% 0.89 Subject 4Rinsate 2.61E+04 91.6% 1.08 Subject 1 Post 3.01E+04 59.5% 0.39 Subject 2Post 2.90E+04 26.1% 0.13 Subject 3 Post 7.04E+04 67.7% 0.49 Subject 4Post 3.40E+04 89.1% 0.96

Conclusions

Post-rinse plate count data demonstrates approximate significantreduction for both water rinse and CML rinse. Analysis of the rinsateplate count data also demonstrates a significant reduction from thebaseline in the water rinse, and even more significant reduction fromthe baseline in the CML rinse. The log reductions present in the waterrinsate suggests mechanical bacterial removal during treatment in theabsence of antimicrobials. The higher log reductions present in the CMLrinsate suggests a combination of mechanical and antimicrobial activityduring treatment.

Though several embodiments have been described, it should be understoodthat the scope of the present invention embraces other possiblevariations, being limited only by the contents of the accompanyingclaims, which includes the possible equivalents.

1. A method for providing a beneficial effect to an oral cavity of amammal, said method comprising: providing an application tray comprisinga liquid-contacting-chamber defined by front and rear inner walls and abase inner wall extending between and integral with the front and rearinner walls, said front and rear inner walls each including a pluralityof openings through which liquid is directed to contact a plurality ofsurfaces of the oral cavity, and providing reciprocation of said liquidover said plurality of surfaces of said oral cavity under conditionseffective to provide said beneficial effect, wherein said step ofproviding reciprocation comprises alternately: (i) directing fluid intosaid chamber through said plurality of openings in said front inner walland out of said chamber through said plurality of openings in said rearinner wall, and (ii) directing fluid into said chamber through saidplurality of openings in said rear inner wall and out of said chamberthrough said plurality of openings in said front inner wall.
 2. Themethod of claim 1 wherein said step of providing reciprocation comprisesusing at least one pump to alternately: (i) directing fluid into saidchamber through said plurality of openings in said front inner wall andout of said chamber through said plurality of openings in said rearinner wall, and (ii) directing fluid into said chamber through saidplurality of openings in said rear inner wall and out of said chamberthrough said plurality of openings in said front inner wall.
 3. Themethod of claim 1 wherein said beneficial effect is selected from thegroup consisting of cleaning said surfaces of said oral cavity,ameliorating a detrimental condition within said oral cavity andimproving the cosmetic appearance of said oral cavity.
 4. The method ofclaim 3 wherein said detrimental condition is selected from the groupconsisting of caries, gingivitis, inflammation, symptoms associated withperiodontal disease, halitosis, fungal infection and sensitivity ofteeth.
 5. The method of claim 3 wherein said cosmetic appearancecomprises whitening of teeth in said oral cavity.
 6. The method of claim3 wherein said liquid comprises an ingredient selected from the groupconsisting of a cleansing agent, an antimicrobial agent, amineralization agent, a surfactant and a whitening agent, in an amounteffective to provide said beneficial effect to said oral cavity.
 7. Themethod of claim 6 wherein said ingredient is selected from the groupconsisting of an alcohol, an essential oil, an abrasive, aperoxide-generating compound and a surfactant.
 8. The method of claim 1wherein said step of providing reciprocation is controlled by a logiccircuit.
 9. The method claim 1 wherein said step of providingreciprocation comprises cycling said liquid between at least onereservoir and said application tray.
 10. The method claim 2 wherein saidstep of providing reciprocation comprises cycling said liquid between atleast one reservoir and said application tray.
 11. The method of claim10 further comprising the step of providing a hand-held devicecomprising said at least one reservoir and said at least one pump. 12.The method of claim 1 wherein said application tray is a mouthpiecedesigned to allow fluid to contact surfaces of the top and bottom teethof the user when positioned in the oral cavity.